Apelqvist 1996.
Methods | RCT Setting: Hospital, 1 centre Country: Sweden Duration of follow‐up: 12 weeks Duration of treatment: Not reported Funding source: For‐profit organisation Unit of analysis: Participant |
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Participants | 41 participants Inclusion criteria: Caucasian > 40 years of age with previously known diabetes, an exudating cavity ulcer below the ankle (Wagner grade I or II) with an ulcer area > 1 cm² and systolic toe pressure > 30 mmHg or a systolic ankle pressure > 80 mmHg. Exclusion criteria: Patients with ulcers > 25 cm², deep abscess, osteomyelitis, or gangrene (Wagner grade III to IV). Patients undergoing investigation of the thyroid gland or unlikely to adhere to study protocol. Ulcer characteristics at baseline (size of ulcer, number of ulcers, duration of ulceration where reported): Not reported Infection status at baseline: Not reported |
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Interventions | Group 1: (n = 19) Gentamicin solution (Garamycin, Schering‐Plough); streptodornase/streptokinase (Varidase, Lederle); dry saline gauze. Group 2: (n = 22) Cadexomer iodine ointment (Iodosorb) changed once daily during the first week and daily or every second or third day in subsequent weeks. Additional comments: All participants were offered the same basic treatment during the study. Prior to inclusion footwear was corrected or special footwear provided whenever required to relieve local pressure. Oral antibiotics used in signs of infection. If the ulcer was infected, gentamicin solution (80 mg/mL) was prescribed twice daily, streptodornase/streptokinase was used for necrotic lesions. Dry saline gauze used as an absorptive dressing with Vaseline gauze used on dry wounds. |
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Outcomes | Primary review outcomes: Proportion of ulcers healed. Secondary review outcomes: Surgical resection; adverse events. |
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Notes | Stratifìcation was based on size and type of ulcer (Wagner grade I to II). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Computer generated list of randomly permuted blocks of patients, the size of the blocks was unknown to the investigator." Comment: Adequate sequence generation |
Allocation concealment (selection bias) | Unclear risk | Comment: No mention of allocation concealment process |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "open‐label" Comment: Assumed staff and participants not blinded to treatment |
Blinding of outcome assessment (detection bias) Wound healing | Low risk | Quote: "... with blinded photo evaluation ..." Comment: Blinded outcome assessment for healing |
Blinding of outcome assessment (detection bias) Infection/resolution of infection | Low risk | Quote: "... with blinded photo evaluation ..." Comment: Blinded outcome assessment for healing |
Blinding of outcome assessment (detection bias) Secondary outcomes | Unclear risk | Comment: No information was provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Patients were withdrawn from the study in case [sic] of hospitalisation (n = 2), lack of compliance (n = 1), violation of inclusion criteria (n = 2)" Comment: Data presented for 35 participants, suggesting 6 dropped out (study started with 41 participants), for a loss of 15%. |
Selective reporting (reporting bias) | Low risk | Protocol not obtained, all outcomes stated in methods reported. |
Other bias | Low risk | None noted. |