Patients' perceptions and experiences of venous leg ulceration and their attitudes to larval therapy: an in‐depth qualitative study

Abstract

Background

Venous leg ulcers are a common and distressing condition that can impair quality of life. Larval therapy has been widely promoted for the treatment of different types of chronic wounds, yet little is known about its acceptability to patients.

Objectives

To explore patients' experiences of venous leg ulceration and of the acceptability of larval therapy as a treatment.

Design

Qualitative study, using semi‐structured interviews alongside a randomized controlled trial. Interview data were transcribed and analysed for thematic content. Data were collected from April 2007 to July 2007.

Setting and participants

Eighteen people (12 men, 6 women), aged between 29 and 93 years (median age 64 years), with at least one venous leg ulcer, took part in the study. Fourteen people were recruited from two vascular clinics (one attached to a hospital and the other located in a community setting). A further four people were recruited through referral from a team of community nurses.

Findings

Participants portrayed lives blighted by the presence of one or more leg ulcers. The majority were willing to try ‘maggots’ (larvae) and able to overcome feelings of squeamishness because of their strong desire to heal their ulcers. Five people treated with larvae were included in the study. Initial improvements in the condition of their ulcers were not sustained, and two participants experienced severe pain.

Discussion and conclusions

Patients may hold unrealistic expectations that larval therapy will effect a longed‐for cure for their leg ulcer(s) but an absence of healing may lead to feelings of disappointment or despair.

Background

Leg ulcers are chronic, recurring wounds on the leg which develop as a consequence of venous insufficiency; arterial insufficiency may also be a contributory problem.1, 2 Venous leg ulcers are common, their prevalence increases with age and in the UK, it has been estimated at 1.7% of people over the age of 65 years.3 Leg ulcers usually take weeks or months to heal, frequently recur, and may be painful, malodorous and produce exudate.4, 5

Almost all aspects of daily life may be negatively affected by the experience of living with a leg ulcer. Several studies have shown that people with leg ulcers have a poor quality of life compared with age‐matched controls.6, 7 In most studies, pain is the dominant complaint,8, 9, 10 although restricted mobility and disturbed sleep are viewed as significantly detrimental to health and well‐being, and discomfort, itchiness and unpleasant smell have been widely reported.6, 11 Negative emotional affects identified include feelings of anger, resentment and depression.12, 13, 14 Further research exploring patients' attitudes towards living with a condition for which there is no current ‘easy’ cure would increase insight into the long‐term impact of leg ulcers on patients’ lives.

Leg ulcers are also costly. The cost to the National Health Service (NHS) of treating venous leg ulcers has been estimated to be £1300 per patient, per annum, at 2001 prices.15 In 2006, the Healthcare Commission estimated venous leg ulceration cost the NHS at least £300‐600 million per year.16

Treatments for leg ulcers aim to improve venous return in the leg and provide a wound environment that supports healing, while at the same time managing symptoms such as exudate. Available evidence supports the use of compression bandaging which aids venous return as an effective treatment for leg ulcers, and this is advocated in major UK guidelines.5, 17 Another important aspect of wound management is thought to be preparation of the wound bed for healing by the removal of devitalized tissue from the ulcer surface, a process known as ‘debridement’.17 Various techniques are routinely employed to ‘clean’ wounds of dead tissue, slough and exudate, including moist dressings (e.g. hydrogels), surgical or sharp debridement to cut tissue away, and enzymes applied topically to the wound surface.18

Recently, there has been renewed interest in larval therapy (also known as ‘maggot therapy’ or ‘biosurgery’), which involves the use of sterile larvae of the green bottle fly (Lucilia sericata) for debridement. These larvae selectively feed on necrotic tissue, leaving live tissue intact. Over the past decade, larval therapy has been increasingly promoted as a treatment for chronic wounds such as leg ulcers,19, 20, 21, 22 despite a lack of robust evidence for its effect on debridement or healing. When we commenced our study, only 12 patients anywhere in the world had been randomized between larval therapy and a comparator, and they had not been followed up to healing.23 Furthermore, there is no strong evidence for a causal relationship between debridement and the healing of chronic wounds: what evidence there is observational in nature and subject to bias and confounding.24

One aspect of the effectiveness of a treatment is its acceptability to patients, and this is particularly important for an unusual intervention such as larvae. Larvae are available in ‘bagged’ or ‘loose’ form: loose or ‘free range’ larvae are placed directly into the wound, while bagged larvae are contained in a meshed polyvinyl alcohol bag. The larvae that are applied to the wound are very small, only a few millimetres in length, and often compared to a grain of rice. However, their size increases while they are on the wound.

Three previous studies25, 26, 27 have investigated patients' attitudes and experiences of the acceptability of larval therapy. Findings indicated that most patients would be willing to try larvae and had no marked preferences for either bagged or loose larvae. However, these studies were limited by their small sample size25, 26 or because they employed a questionnaire format,27 potentially constraining responses from participants. The study by Spilsbury et al27 preceded the Venus II randomized controlled trial and was entirely different from the study reported here. This paper reports results from an in‐depth interview study with 18 people designed to explore their views and experiences of leg ulceration and larval therapy.

Design

Ethical considerations

The study received research ethics (MREC reference: MREC/03/7/049) and governance approval. All participants were given verbal and written information relating to the study aims and their involvement. Written consent was obtained and participants were given assurances concerning the confidentiality and anonymity of their responses. Participants were also reassured that their care would not be affected in any way, whether or not they decided to take part in an interview, and that they could withdraw from the study at any time.

Participants

Study participants (N = 18) were recruited from three clinical sites participating contemporaneously in the VenUS II randomized controlled trial.28 Purposive sampling was used to ensure representation from patients who received their leg ulcer care in different clinical settings (at home and in clinics), inclusion of people of minority ethnic origin and of people who had, and had not, experienced larval therapy as treatment for their leg ulcer. Fourteen participants were recruited from people attending either a hospital vascular clinic or a community leg ulcer clinic. A further four participants receiving treatment for leg ulcers in their own homes were recruited through referral from a team of community nurses.

Details of study participants are given in Tables 1 and 2, based on their previous experience of larval therapy. To summarize, participants' age ranged from 29 to 93 years (median age, 64 years). Six participants were women. Fifteen participants were White British, one (man) was South Asian, one man was Iraqi and one (woman) was Black Caribbean. Duration of participants' current ulcer ranged from one month to 9 years (median, 36 months; mean, 44 months). Five of the 18 participants (three men and two women) had experienced larval therapy.

Table 1.

Participants who had not previously had leg ulcer treated with larval therapy

Patient ID	Sex	Age	Ethnic origin	Lives with family (yes/no)	Duration of ulcer (months)
P1	M	67	White British	Yes	12
P2	M	61	White British	Yes	6
P3	M	65	White British	Yes	18
P4	F	62	White British	Yes	72
P5	M	31	White British	Yes	36
P6	M	69	White British	Yes	108
P7	M	63	White British	No	1
P8	M	70	White British	Yes	96
P10	F	71	White British	Yes	12
P12	M	45	South Asian	No	72
P13	F	76	Black Caribbean	Yes	60
P14	M	29	Iraqi	No	60
P16	F	76	White British	Yes	6

Table 2.

Participants who had previously had leg ulcer treated with larval therapy

Patient ID	Sex	Age	Ethnic origin	Lives with family (yes/no)	Duration of ulcer (months)	Larval therapy (loose)	Larval therapy (bagged)
P9	F	68	White British	Yes	30	No	Yes
P11	M	52	White British	Yes	36	No	Yes
P15	M	82	White British	Yes	72	Yes	No
P17	M	93	White British	No	84	No	Yes
P18	F	66	White British	Yes	12	Yes	No

Nurses (N = 22) were also interviewed for the qualitative study, and findings from these interviews will be reported at a future date.

Data collection and analysis

Interviews were conducted by the researcher (DM), audio‐recorded and fully transcribed. Data were analysed for thematic content, using a modified ‘Framework’ approach29 following sequential steps of familiarization with the data, thematic analysis and development of a coding scheme, indexing, mapping and interpretation. This analytic process is systematic but constitutes more than a mechanistic approach to analysis as it relies on the conceptual abilities of the analyst to determine meaning, salience and connections.30

DM read all the transcripts and developed a coding framework that allowed for linkage between individual participants and their responses and reflected patients' attitudes and experiences of receiving larval therapy. To promote transparency, enhance rigour and ensure trustworthiness of the findings,31 an experienced qualitative researcher who was independent of the study was asked to check the coding of three interviews.

Findings

Predominant theme – ‘I'll try anything’

Most (15 of 18, 83%) people interviewed were willing to accept (or had accepted) the use of larval therapy as a treatment, in either bagged or loose form. Importantly, this willingness to try larval therapy (usually referred to by participants as ‘maggots’) was closely linked to their feelings of desperation for any improvement or cure for their leg ulcer, exemplified in the phrase ‘I'll try anything!’, a recurring theme throughout the interviews.

Patients in the study portrayed the negative impact of their leg ulcer(s) on their own (and their families') lives. They reported pain, restricted mobility, weight gain, odour, disturbed sleep (their own and their partners') loss of physical and economic independence, reliance on medication, social embarrassment and low mood and depression. In addition, the need for on‐going treatment was perceived as time‐consuming and restrictive, due to regular visits to, or from, nurses to have bandages and dressings changed, with curtailment of social activities and travel plans (see Box 1).

Box 1. Patients' experiences of living with a leg ulcer. (‘P’ stands for ‘participant’.).

‘You get quite depressed, the pain is obnoxious, absolutely obnoxious’ (P10)

‘I'd rather sleep downstairs on the chair, I have a nice big leather recliner…upstairs you've nothing to take your mind off the pain…if I put the radio on it disturbs the wife… (P6)

‘it does affect his walking, there are times when it is very painful and his mobility is poor’ (interpretation of words of (P12))

‘I can't walk…I can't go out…so I do miss going out’ (P16)

‘it hurts me a lot and sometimes makes me fed up with life’ (interpretation of words of (P14))

‘it's like rotten cabbage…like a stinky cabbage’ (P6)

‘the doctor gave me painkilling tablets and I can take up to 8 a day’ (P16)

‘the girls [community nurses] were coming every day and put all sorts on…’ (P17)

Most patients in the study had already experienced a wide range of treatments for their leg ulcer (see Table 3) with varying results. Participant 9 simply stated that she had tried ‘everything under the sun’. Each time, a ‘new’ treatment was tried, their hopes were raised, but often the ulcer showed little or no sign of improvement, or improvement was not sustained, leading to recurring episodes of deep disappointment. Feelings of hopelessness and powerlessness pervaded the accounts of a number of participants who said they could foresee no end to the repeated cycles of treatment and failure.

Table 3.

Leg ulcer treatments (other than larval therapy) experienced by patient participants

Patient ID	Compression bandaging	Honey	Hydrogel	Ointment	Dressings	‘Zip sock’	Ultrasound
P1		√
P2	√		√
P3	√			√
P4		√		√
P5	√
P6	√				√		√
P7	√				√
P8	√		√
P9							√
P10	√				√	√
P11	√				√
P12	√	√
P13	√				√	√
P14	√			√
P15	√	√		√	√
P16	√	√
P17		√			√
P18	√			√		√

While some participants appeared to have complete faith in professional expertise, others voiced concerns about the effectiveness or side‐effects of the various treatments used on them, or about the ways in which they were administered (see Box 2).

Box 2. Patients' perceptions of experiencing a range of treatments. (‘P’ stands for ‘participant’).

‘they [the nursing staff] tried honey at first, but it was too painful when it first broke down, it was too much, they're using now like an iodine ointment’ (P1)

‘I've been on the machine [ultrasound] once and they got it up to standard and it was marvellous…and then it just deteriorated…’ (P9)

‘they come wafting dressings in front of me.. they did it with that silver dressing, that was terrible, and then another one – the liquid was just pumping out of my leg, it just went crazy’ (P10)

‘I just feel it's not getting anywhere…you get a bit, ‘Oh, I wish it would be over and done with’, I think where they went wrong at first, they bandaged my leg up so it was like a balloon…they wrapped it up and wrapped it up, and I think my skin underneath just died…and then a dermatologist came here and he said ‘Oh, I don't want any of that on, take it all off’…the trouble is, you never see the same person twice..one [nurse] emptied half a tube of cream on, it just set my leg on fire and my wife had to take it off overnight, and then we just went back to the ordinary NAs [non‐adherent dressings]' (P15)

Viewed in this context, it is perhaps not surprising that the majority of patients were willing to try ‘maggots’ (larval therapy) in a last ditch attempt to find amelioration or cure for their ulcer. Frequently, the patient was supported in their decision to try maggots by another family member, usually their spouse, whose life could be equally disrupted and diminished as a consequence of the existence of the leg ulcer (see Box 3).

Box 3. Participants' attitudes to trying ‘maggots’. (‘P’ stands for ‘participant’.).

‘I'd be perfectly willing to try them because I've been coming here for weeks and weeks, bandaging and bandaging…with maggots, I think it'd move quicker’ (P6)

‘stick them on by all means, if they are going to help me, stick them on!’ (P7)

‘with leg ulcers, they're painful and you can't find a cure for them, so you'll do anything… they are a horrible thing and I've had lots of pain, worse things, but I've never had anything like this, I would never wish it on anyone’ (P11)

‘anything for my leg's benefit, I am ready to do it’ (P 14)

‘it has gone on and on and on…we said we would try anything…if that is the ideal way of curing an ulcer, go ahead full steam’ (Participant 15 interviewed with his wife present)

Factors associated with a willingness to try larval therapy included prior knowledge of, or contact with, maggots, positive health beliefs about the effectiveness of larval therapy, an open‐minded approach towards new or ‘alternative’ therapies, an absence of, or willingness to overcome, any feelings of squeamishness on the part of the participant or their family members and a positive approach from the health‐care professional proposing larval therapy as a treatment option. Conversely, people who said they would be unwilling to try larval therapy reported that they had had little or no previous contact with maggots, described themselves (or their partner/spouse) as ‘squeamish’ and appeared sceptical about the potential benefits or larval therapy. The influence of each of these factors on willingness to try larval therapy is discussed in more detail below, before turning to examine the expectations and actual experiences of the five participants in the study who had undergone larval therapy.

Prior knowledge of, or contact with, maggots and positive beliefs

Study participants who demonstrated a willingness to try larval therapy were relatively well informed and held positive views of how maggots might be beneficial for their ulcer. Television, newspapers, books about the First World War and magazine articles, along with verbal accounts from nurses, friends and fellow patients attending leg ulcer clinics, all contributed to patients' knowledge. Most people said maggots ‘ate’ ‘bad’ or infected tissue with little or no damage to healthy tissue. Several patients recalled TV programmes or magazine articles in which maggots appeared to be highly effective at cleaning infected wounds or achieving a dramatic ‘cure’ in a seemingly hopeless case. As a result of information from the media, Participant 11, who had suffered severe pain and other symptoms from numerous leg ulcers over a long period of time, made a request to his GP for larval therapy. He encountered a lack of interest on the part of the doctor but pursued his request through other channels, determined to obtain the treatment he wanted (see Box 4).

Box 4. Participants' prior knowledge and beliefs about larval therapy. (‘P’ stands for ‘participant’.).

‘they eat the dead flesh, skin, everything that is dead they clear away and you are left with a clean wound’ (P17)

‘I've read about them…there's a supplement in the Daily Mail or the Express where they talk about medical things and it has cropped up from time to time, where they were experimenting with maggots’ (P10)

‘I was reading an article about a young lady and…she reckoned she would have to have her foot off, but they put the maggots on and the maggots must have ate all the badness or whatever…and she doesn't have to have her foot off…’ (P7)

‘they [medical staff] didn't suggest it [larval therapy]. I told them I wanted it. I'd heard radio, and television programmes about it… so I tried the GP and they didn't seem interested, and I tried at the clinic I was going to at the time and they just didn't do owt and then when I went to [clinic] I said something has to be done because it was stinking, it was awful and the doctor agreed…and I just said, ‘tell them to get the maggots straight on’ (P11)

Seven of the 12 male participants had observed or handled maggots either whilst fishing or through farm work. Two of these participants described holding or ‘rolling’ maggots in their mouths for fishing. None of the female participants mentioned that they had handled maggots, and only two said they ever had seen them. Of the five participants who had received larval therapy (three men and two women), two of the males said they had had experience of handling maggots, while the other three participants (one man and two women) had not.

An open‐minded approach to new or ‘alternative’ therapies

Participants willing to try larval therapy demonstrated an interest in new or ‘alternative’ therapies and were open to trying novel health‐care technologies for which there was no established evidence base available. These respondents were proactive in seeking out cures for leg ulcers, for example, by searching the Internet for information or by acting on recommendations from others to try different treatments.

Two of the patients interviewed had volunteered to take part in clinical trials. Participant 10 had responded to a request from a health professional to take part in a trial of ultrasound to treat leg ulcers, and Participant 18 decided to participate in VenUS II28 after her husband had spotted an advertisement promoting recruitment in her local newspaper. Participant 18 explained that she preferred to try alternative remedies for any ailments she experienced before ‘going down the traditional route’ and that she had had homoeopathy and acupuncture in the past for various conditions (see Box 5).

Box 5. Participants' attitudes to novel and ‘natural’ therapies. (‘P’ stands for ‘participant’.).

‘I find it interesting that medicine in general is going back to methods that we used 150 years ago…leeches used for the anticoagulant and so many herbal remedies that are actually the source of the drugs they give in tablet form’ (P1)

‘at Christmas, when this [her ulcer] was really going bad, [name] said, ‘why don't you go on one of our trials?’, so I said, well, I have nothing to lose…’ (P10)

Absence of, or willingness to overcome, feelings of squeamishness on the part of the participant or their family

The majority of participants who were predisposed to accepting larval therapy reported an absence of feelings of squeamishness in relation to larvae or said they would be able to overcome such feelings if they thought the application of maggots would help their leg ulcer. The attitudes and feelings of family members were clearly influential in patients' decision making. Participant 1 said his wife was as ‘fascinated’ by maggots as he was himself and that she encouraged him to go ahead and try them. Participant 18 commented that it was her husband who suggested she try larval therapy and that he was ‘quite happy with the idea’. Participant 15's wife (who was present during his interview) said that she had overcome her own feelings of distaste to support her husband to try larval therapy. Although her initial reaction to the thought of it had been to exclaim ‘Yuk!,’ she was alongside her husband to watch while the nurse applied the larvae and removed them.

Impact of the presence of feelings of squeamishness on likelihood of accepting larval therapy

Strong feelings of distaste or disgust associated with maggots on the part of a patient or their spouse appeared to be the factor that was most indicative of a patient saying that they would reject (or had rejected) larval therapy. Quotations from the interviews of two participants are used to illustrate this point. Interestingly, Participant 8 and Participant 16, who initially said they found the prospect abhorrent, seemed willing to change their mind, according to how well informed they felt about the nature of larvae and their effectiveness. Only one participant (Participant 13) from the total study sample of 18 respondents stated categorically that she would not accept maggots as a form of therapy, due to her deep‐seated feelings of disgust and her scepticism about their likely effect. Her own views were reinforced by those of her husband.

Quotations from interview with Participant 8

Participant 8 was a 70 year old male, born in the UK, who had had a leg ulcer for 8 years. He described his own distaste for ‘creepy crawlies’ as a family trait inherited from his mother and said he would be unlikely to accept larval therapy because his wife would never tolerate maggots in the house. Though he said he might try to overcome his own distaste if he was convinced that larval therapy would be effective, he would nevertheless still have to take his wife's feelings into consideration.

‘With my wife, it's not just the question of ‘I don't want to touch them, I don't want to see them, it's a question of ‘I don't want maggots in the house!’

‘if I had, as I say, a 75/25 chance of recovering with the use of them, I would personally be prepared to go along with it, but not at the expense of any of my family…’

Positive approach by health‐care professional when proposing larval therapy as a treatment option

Participants' views about the acceptability of leg ulcer treatments advocated by health‐care professionals (mainly nurses) ranged along a continuum, from complete trust in professional expertise to a more questioning attitude, seemingly associated with the number of treatment failures that the patient had experienced. For some patients, the way in which a new treatment was presented to them could be an important factor in their deciding whether or not to accept it.

Of the five respondents who had undergone treatment with larval therapy, four had had the larvae applied in their own homes by members of the community nursing team who were well known to them and their families. These patients indicated that they shared a good rapport with the community nurses, whose professional judgement they respected. They cited the aspects of the nurses' approach which led to them accepting larvae: giving information about the different forms of treatment (bagged and loose); describing what maggots look like, thereby allaying anxiety; giving reassurance that larvae would not harm healthy tissue; and drawing the patient into the decision‐making process (see Box 6).

Box 6. Participants' views of nurses' approach. (‘P’ stands for ‘participant’.).

‘and so [name of nurse] said, ‘we'll try maggots, if you don't mind’, she asked me first, I am sure that some people are afraid of maggots…for the majority of people, it is an unknown quantity…and the mere mention of maggots puts them off' (P17)

‘apparently they devour the bad cells do they not?, [nurse] said they eat the bad skin’ (P9)

‘[name of nurse] had told me that they are very thin, they are sort of almost like an eyelash…if they had been big fat things I might not have been so happy about it’ (P18)

By contrast, Participant 11 had instigated the use of larval therapy as a treatment for his leg ulcer himself, and had received the treatment in hospital, from the nurses he had not met before whose expertise he questioned.

Quotations from interview with Participant 16

Participant 16 was female, in her mid‐70s, and had suffered recurrent leg ulcers over a long period of time. She had spoken to her son about larval therapy on the day of her interview; apparently he had urged her to consider it as a potential treatment. At the start of the interview, asked if she would be prepared to undergo larval therapy, Participant 16 signalled her disgust by grimacing and expressing her fear that they would burrow into her flesh in some way.

‘Oh God, no, no, no way, maggots!’

‘they are creepy crawly things, and where do they go…do they go inside your leg…you don't know, do you?’

However, as the interview proceeded and she learnt that larval therapy could be applied in bagged form, her reaction changed.

‘that would make a difference to me, because then I would know where they are’

Participants' expectations and experiences of larval therapy

Three male (P11, P15 and P17) and two female participants (P9 and P18) had experienced larval therapy as a treatment for their leg ulcer. Three of the five (P9, P11 and P17) had experienced bagged larvae and two (P15 and P18) had experienced loose larvae. In reporting their expectations and experiences of larval therapy, these respondents referred to pain, the appearance of larvae, and their own and family members' perceptions of the effectiveness of the treatment. Participant 11, who underwent larval therapy in hospital, reported his experience as highly unsatisfactory.

Pain

Only two of the five people treated with larval therapy reported experiencing pain. Participant 9 and Participant 18 (both women) appeared shocked by the sudden onset of intense pain that they suffered almost as soon as the larvae were applied. They both reported being prepared to put up with a certain amount of pain if necessary, and both believed they had a high pain threshold, but neither of them had anticipated the level of pain they experienced. As a result, both women requested that the larvae were removed sooner than planned. Participant 9 commented that the pain was so severe that it triggered angina, while Participant 18 described shooting pains in her leg that were like ‘knives’. Participant 18 attributed the pain to a reaction to the enzymes, as this was the explanation given to her by the nurse who removed the larvae. By contrast, the male participants had not expected any pain, and neither did they report any beyond minor discomfort just before the maggots were removed (see Box 7).

Box 7. Participants' expectations and experiences of pain. (‘P’ stands for ‘participant’.).

‘the pain was so severe to give me an angina…I couldn't stand it any longer so [nurse] came and took them off, she didn't hesitate’ (P9)

‘I wasn't expecting pain at all really and it sounds like in a lot of cases people don't get pain’ (P18); ‘it was like shooting pains coming up my leg, almost like knives going into it…the sort of pain where I just didn't know what to do with myself’ (P18)

‘I had pain all the time, it didn't go up or down because of the maggots’ (P11)

‘with the maggot treatment it [his ulcer] was never sore, I didn't even feel it was there…it didn't affect me during the day and it didn't affect me at night… no, the last day you get a bit irritable, you wanted them off’ (P15)

‘you can't feel anything, you can't feel a thing, or at least I didn't’ (P17)

Appearance of larvae

Participant 15 and Participant 18, who both experienced larvae in loose form, commented the larvae were much smaller in appearance than they had expected. Expecting to see maggots similar to those used for fishing – ‘big fat things you see wriggling around’ (P18) – both patients were instead pleasantly surprised by their actual appearance, which made the process of application more acceptable and less disturbing. Participant 15 commented that the nurse had told him that the maggots would be ‘very thin’ and added that ‘the fact that they weren't these fat maggots that most people know about, I think that made a difference’. Participant 18 described the larvae applied to her leg as looking ‘like an eyelash’ while Participant 15 referred to ‘little wisps of hair so small you can hardly see them…you can't imagine they are maggots, not when they are going in’.

Asked how they felt about the maggots' appearance on removal, when they would have increased in size, participant 18 commented that she was not as perturbed as she had imagined she might be, saying ‘the thought is worse than the act’. P15 and his wife both watched as the nurse removed ‘a hundred plus’ larvae from his leg after 3 days, and then shared a laugh because the following day ‘one more maggot rolled out’ from his wound; he pointed out that a patient would not have to watch the maggots being removed if they didn't wish to.

Of the five participants who experienced larval therapy, only Participant 18 expressed a mild preference for bagged larvae, but in volunteering to participate in VenUS II, she had realized she might be randomized to either the bagged or loose form and was prepared to accept either (see Box 8).

Box 8. Participant 18's views on method of containment. (‘P’ stands for ‘participant’.).

‘I suppose if I thought they were in a bag, I am not going to have to see them so much, I think…in the bag, I might have preferred that, but I didn't mind having them loose, but I think in a way there was this feeling of them being a bit more contained, rather than having sight of them’ (P18)

Perceptions of effectiveness of larval therapy

Three of the five participants (P9, P17, P18) who experienced larval therapy remarked on the speedy visible improvement that ensued in the appearance of their leg ulcer. They mentioned specifically a noticeable reduction in the amount of slough in the wound, resulting in a ‘clean' ulcer bed. Initial results seemed to match patients’ high expectations, in line with their prior beliefs that maggots offered a powerful means of treatment. Unfortunately, the initial improvement was not sustained, and these patients went on to report that their ulcers deteriorated soon after the removal of the larvae.

Of the two remaining participants, Participant 15 was informed by nursing staff that there was little change in the ulcer after the application of larvae, although he himself seemed to value the fact that the wound had been made clean, even though the ulcer continued to remain unhealed. Participant 11 was disappointed with his experience of larval therapy.

With the exception of Participant 11, study participants who experienced larval therapy retained their positive prior attitudes. Where the experience of having larvae applied was deemed positive (for example, if the wound appeared cleaner), then participants' views of the beneficial effects were reinforced. Even the two female participants (P9, P18) who reported a negative experience due to pain, maintained that larvae had benefitted their ulcer, as they had hoped, despite the short span of time that the larvae were in situ.

Of the patients who had had larval therapy, only Participant 18 commented that she thought loose larvae might be more effective than bagged (see Box 9).

Box 9. Participants' views of effectiveness of larval therapy. (‘P’ stands for ‘participant’.).

Larvae perceived as effective for cleaning (if not healing) ulcers

‘[nurse] thought it [the ulcer] looked cleaner after she took them away, she could see a difference,,,she said they had cleaned it up…’ (P18)

‘I felt my leg when they took the maggots off was cleaner…but at the moment…there is a big [crater] the area is not healing, as always, it is growing, yeah, you can see it growing…well they [the nurses] said it [larval therapy] didn't do me any good…’ (P15)

‘I've had maggots which I thought were a wonderful, wonderful thing. I truly believe in them… but the only trouble was I couldn't keep them on a third night, but they did do a marvellous job, they did clear a lot of the slough away…it was too painful…I couldn't have stood it any longer…they had done their job by then… and then it deteriorated again’ (P9)

Uncertainty concerning effectiveness of larvae and form of application

‘maybe if they are in a bag, maybe they aren't doing their job as well’ (P18)

Fear of feelings of disappointment

Participant 11 had received larval therapy in hospital for a large necrotic ulcer, from nurses he did not know, who, he said, were unfamiliar with the use of larval therapy, so that he questioned their competence. He commented that during his stay he had felt like ‘a peep show’ as nurses came to watch other staff apply the larvae. Participant 11 was unsure whether the treatment he had received in hospital had effected any change for the better. He said he had dreaded the disappointment of discovering little or no change in the condition of his ulcer so refrained from looking when the larvae were removed, adding that he did not trust the nurses to give him a reliable assessment of its condition (see Box 10).

Box 10. Perceptions of Participant 11 regarding his experience of larval therapy.

‘I was disappointed, they were actually put on by someone who hadn't really done it before, it wasn't one of the Tissue Viability Nurses…it were people who had to read the instructions on the packet…they were feeling their way’

‘it was taken off every day and re‐arranged and re‐hydrated and redressed and every time people used to say ‘Oh yes, that is a bit better’, but you don't know if they are just saying that to be honest… I just thought, if I looked at it and found out it wasn't improving as much as I wanted it to improve I'd be upset about it’

Excerpts from interview with Participant 11

Summary of main findings

The main factor that appeared to influence patients' willingness to try larval therapy was their desperation to ‘try anything’, which might lead to a cure for their ulcer. Study participants drew on information from books and the media to construct their own ‘evidence base’ for the effectiveness of ‘maggots’ resulting in a strong credence in their healing powers. Participants who received the therapy with little or no improvement in their leg ulcer even expressed a willingness to try it again and to recommend it to others. This apparent contradiction may reflect participants' reluctance to give up hope of ultimately finding a cure for their ulcer.

Other influential factors that appeared to impact on participants' willingness to accept larval therapy included: prior knowledge and contact with maggots, openness to novel or ‘alternative’ approaches to health‐care treatments, support from a spouse, the manner in which nurses ‘sell’ maggots as a viable treatment option and the context in which the therapy is delivered.

The presence of feelings of squeamishness or disgust in the patient or a spouse was likely to lead participants to reject the treatment.

Discussion

Principal findings

Patients in the study who suffered from leg ulcers, whether multiple or single, for a relatively short period of time, or over a number of years, reported how their lives were circumscribed and diminished by pain, loss of independence, feelings of social isolation and, frequently, profound feelings despair that their ulcer would never be cured. Patients appeared frustrated and disappointed as each new treatment they tried held out hope, but then failed, to result in a permanent cure for their ulcer. It is hardly surprising, therefore, that our study findings suggest that most people would be willing to consider larval therapy as a treatment for leg ulcers, in either form.

Only two of the 18 participants included in the study expressed a preference for bagged larvae. Containment seemed to offer these patients a degree of reassurance that the larvae would remain in situ, helping to quell the thoughts of maggots crawling freely over, or burrowing into, flesh. Participants who revealed their own or a family member's deep‐seated feelings of squeamishness or disgust in relation to ‘creepy crawlies’ were averse to the notion of having larval therapy.

Participants' hopes and expectations that larval therapy would result in long‐lasting improvement or cure of their ulcer were not borne out by their experiences. Five of the study sample underwent treatment with larvae, and four were pleased to find a visible improvement in the state of the ulcer when the larvae were removed due to debridement of slough. However, these patients reported that soon afterwards the condition of their ulcer deteriorated again. Despite the lack of success in terms of healing, patients' beliefs in larval therapy as an effective treatment option were not shaken. Participants welcomed the opportunity to try the treatment and were happy with the outcome obtained – the larvae cleaned their ulcer and reduced odour and exudate. Cleaning of the ulcer bed was valued per se, even when if it was not followed by healing.

Pain was a significant unanticipated side‐effect of treatment for two of the five patients who had received larval therapy. Both participants had reported having a high pain threshold, and both were well informed and keen to try the larvae prior to their application. However, in both cases larvae were removed early at the patients' request, due to severe pain, and pain has been a previously reported consequence of larval therapy.32, 33

The majority of participants interviewed had heard about larval therapy through the media or from speaking to family, friends and health‐care professionals. Media and other reports may have led to patients holding unrealistic expectations of the power of larvae to achieve a ‘miracle cure’. Although almost all the participants had heard of maggots being used to clean wounds, they were largely unaware of the mechanism of action. Most people commented that larvae would ‘eat’ ‘bad’ or necrotic tissue; two of the female participants feared that maggots might ‘burrow’ into their flesh.

Patients' expectations concerning the appearance of larvae were generally confounded – they were pleasantly surprised to find that they did not look like the maggots they associated with fishing and that they were much smaller in size. The words nurses chose to describe larvae (for example, comparing them to ‘an eyelash’) when proposing the therapy seemed to make a deep impression on patients and offer reassurance.

Patients in our qualitative study reported that the condition of their leg ulcer deteriorated soon after the removal of larvae. These anecdotal reports reflect the quantitative results from the Venous Ulcer Study II (VenUS II) randomized controlled trial28 alongside which our qualitative study was undertaken. Results from VenUS II indicate that whilst larval therapy cleans sloughy or necrotic venous or mixed aetiology leg ulcers more rapidly than hydrogel, it does not speed healing nor reduce bacterial load.

Strengths and weaknesses of the study

Our study was purposively designed to elicit patient views and experiences of larval therapy, in bagged and loose form, and is the largest interview study of its kind. Participants were selected to ensure the inclusion of people receiving leg ulcer treatment in different clinical settings (at home and in clinics), people of minority ethnic origin and people who had and had not experienced larval therapy as a treatment for their ulcer. Interviews were based on a semi‐structured interview schedule to promote consistency across the data set, but the instrument employed was flexible enough to explore patients' views in sufficient depth to generate ‘rich’ data.31 Previous related studies have been on a smaller scale25 or based on case studies34, 35 or convenience samples selected from a single clinical setting, in which responses were drawn from questionnaire surveys of participants' answers to specific questions, with limited the opportunity for further exploration.26, 27

More men than women (12 of 18) were recruited into our study, and therefore, the sample does not reflect the distribution of the chronic leg ulcers amongst the general population, as they are more prevalent in women.36

Seven of the male participants had had prior contact with ‘maggots’ through farm work or fishing, a factor which appeared to predispose these participants to accepting larval therapy. Of the six female participants, two were reluctant to accept larval therapy but we cannot infer that their refusal was linked to gender rather than other individual characteristics, although previous work has suggested that older (>70 years) women are less inclined to accept larvae as a treatment.27

Results in the context of other studies

Our findings concur with previous work26, 27 reporting patients' willingness to try larval therapy, in any form, arising from a strong desire to find a cure for their ulcer.

Spilsbury et al27 conducted a study in the UK in which 35 participants attending a venous ulcer clinic were interviewed using a brief structured questionnaire about their preference for loose or bagged larval therapy, or standard treatment (hydrogel), and for their views regarding the use of larvae as a treatment. These authors found that larval therapy was acceptable to the majority of participants surveyed, irrespective of method of containment and that study participants were motivated to try larval therapy by their longing to achieve healing for their ulcer.

In his phenomenological study of 6 patients, Kitching25 found that patients initially expressed revulsion at the prospect of receiving treatment with larvae. By contrast, our study indicated only a minority of participants (3 of 18) would be deterred from trying the treatment due to feelings of squeamishness or distaste. Our findings mirror those of Steenvorde et al.26 who carried out a questionnaire study with 37 hospital patients with long‐standing non‐healing wounds where all participants expressed a willingness to try larval therapy and subsequently went on to receive the treatment.

Kitching's25 study highlighted the role of the nurse in reducing anxiety in patients considering larval therapy, and we also found that the way in which nurses conveyed information about the treatment appeared instrumental in reassuring patients.

The strength of our study however lies in the in‐depth interview technique that allows more thorough exploration of participants' feelings, views and experiences. This enabled our understanding to be developed of the sheer desperation felt by many leg ulcer patients which greatly explains their willingness to ‘try anything’ – including a willingness to re‐try treatments that have previously been unsuccessful.

Our findings suggest that some participants undergoing treatment with larval therapy may experience a substantial increase in pain which they attribute to the treatment. Previous research presents conflicting findings regarding pain: in Kitching's25 small qualitative study, patients reportedly experienced a reduction in pain when treated with larval therapy; elsewhere, patients experienced increased pain32, 33 while for some, there was no effect.37 Reasons suggested in the literature for increased ulcer pain during treatment with larval therapy include a change in wound pH and participants with neuropathy having increased sensitivity to the movement of the larvae or to chemicals secreted by the larvae.38, 39

Conclusions and implications

It is well established that leg ulcers have a profound impact on quality of life6, 12, 13 and sufferers appear willing to try any form of treatment that holds out hope of a cure, whether or not there is research evidence of effectiveness. Larval therapy appealed to participants in our study as a novel remedy which they had yet to try, which they had heard of from a variety of sources and which might result in healing of their ulcers and an end to their suffering. However, those who experienced the treatment found that their hopes for healing remained unfulfilled. This finding concorded with evidence about larvae from the randomized controlled trial (VenUS II) 28 Results from VenUS II indicated that while larval therapy (compared to hydrogel) may be a useful aid to debridement of sloughy and/or necrotic mixed venous/arterial ulcers, it does not increase the rate of healing and is associated with more pain.

Clinicians are faced with a difficult challenge in trying to balance the need to find effective treatment options that work for patients with leg ulcers, while managing patients' expectations for a cure, which may be unrealistically high.

Imparting hope to patients whatever the nature of their condition is often regarded as a fundamental principle of caring40 but raising false hopes in the quest to find an optimal treatment for an individual's leg ulcer(s) may arouse feelings of disappointment, disillusionment and distrust. These negative emotions may trigger a ‘spiral of hopelessness’6 in patients for whom professional attention is focussed on an outcome that may never be achieved. Health‐care professionals are therefore required to think carefully about how they present information about potential treatment outcomes to patients with leg ulcers.

Findings from recent studies6, 12, 41, 42 suggest that a major challenge facing clinicians dealing with patients with ‘hard‐to‐heal’ ulcers is the need for a shift in focus from healing alone, towards a broader consideration of the patient's needs, including symptom control and emotional concerns. Rather than focusing all their efforts on attaining healing, nurses need to discuss with patients how together they can develop and implement strategies to manage their non‐healing or recurrent ulceration as an enduring condition. Further research, possibly incorporating psychological approaches, is required in this area to help health‐care professionals deliver interventions that improve patients' quality of life in the face of this long‐term condition.

Source of funding

The project was funded by the UK National Institute for Health Research Technology Programme (project number 01/41/04). The views and opinions expressed do not necessarily reflect those of the Department of Health.

Authors' contributions

DM and JD were responsible for data collection. DM was responsible for data management and preliminary analysis of data. DM, NC and JD contributed to the planning of the study and the interpretation of data. All named authors have read and approved the manuscript.

Disclaimer

This project was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 01/41/04) and has been published in full in Health Technology Assessment. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.

Conflicts of interest

None.