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. 2020 Jan 22;2020(1):CD012196. doi: 10.1002/14651858.CD012196.pub2

Ahmad 2008.

Methods Design: 5‐week multicentred randomised controlled study
Participants Health condition: people with chronic pressure ulcers
Sample size:

  • Randomisation: at participant level (one ulcer per participant)§

  • Randomised (participants, n; ulcers, n): 60; 60

    • Experimental 1: 15; 15

    • Experimental 2: 15; 15

    • Experimental 3: 15; 15

    • Control: 15; 15

  • Analysed (participants, n; ulcers, n): 60; 60

    • Experimental 1: 15; 15

    • Experimental 2: 15; 15

    • Experimental 3: 15; 15

    • Control: 15; 15


Setting, country: not reported (4 sites), Egypt
Inclusion criteria:

  • aged between 30 and 50 years

  • stage II pressure ulcers (Yarkony‐Kirk classification)

  • pressure ulcers between 4 cm2 and 10 cm2

  • no gender restriction


Exclusion criteria:

  • pregnancy

  • participants with a pacemaker, peripheral vascular disease and active osteomyelitis

  • participants receiving radiation therapy, steroid therapy or chemotherapy


Characteristics of pressure ulcer:

  • Experimental 1

    • Ulcer duration, mean (SD): 4.4 months (0.9)

    • Ulcer location: not reported

    • Ulcer stage (%): stage II (100)

  • Experimental 2

    • Ulcer duration, mean (SD): 4.4 months (0.9)

    • Ulcer location: not reported

    • Ulcer stage (%): stage II (100)

  • Experimental 3

    • Ulcer duration, mean (SD): 4.5 months (0.9)

    • Ulcer location: not reported

    • Ulcer stage (%): stage II (100)

  • Control

    • Ulcer duration, mean (SD): 4.5 months (0.9)

    • Ulcer location: not reported

    • Ulcer stage (%): stage II (100)


Mean age (SD):

  • Overall: not reported

  • Experimental 1: 38 years (7)

  • Experimental 2: 38 years (2)

  • Experimental 3: 39 years (2)

  • Control: 39 years (2)


Gender:

  • Experimental 1: 40% male

  • Experimental 2: 47% male

  • Experimental 3: 53% male

  • Control: 60% male


§It is not clearly stated whether participants or pressure ulcers were randomised but the number of pressure ulcers equals the number of participants.
Interventions Total groups in this study: four
Experimental 1: high voltage pulsed galvanic current administered for 45 minutes plus cointervention

  • Duration: 45 minutes per session; 1 session per day; 7 days a week; total 5 weeks

  • Electrode placement: one over the ulcer and the other strapped around the medial thigh

  • Device, manufacturer: a small portable high‐voltage monophasic twin‐pulsed generator, manufacturer not reported

  • Intensity of ES: a minimal voltage just capable of producing a visible muscle contraction

  • Frequency: 120 Hz

  • Type of current: pulsed

  • Polarity:

    • active electrode with negative polarity for first 3 days

    • then dispersive electrode with negative polarity until the ulcer healed or healing plateaued

    • the above protocol was restarted if healing plateaued


Experimental 2: high voltage pulsed galvanic current administered for 60 minutes plus cointervention

  • Same settings and duration as Experimental 1 but stimulation was administered for 60 minutes per session


Experimental 3: high voltage pulsed galvanic current administered for 120 minutes plus cointervention

  • Same settings and duration as Experimental 1 but stimulation was administered for 120 minutes per session


Control: sham high voltage pulsed galvanic current administered for 45 minutes plus cointervention and conventional wound therapy

  • Same settings and duration as Experimental 1 but without current


Conventional wound therapy included a wet dressing and 4‐5 whirlpool therapy sessions per week and an intensive amount of additional care (including the maintenance of a moist wound microenvironment).
Cointervention for all groups

  • All ulcers were debrided before delivering any intervention
Outcomes Outcomes included in this review: presented as [name of outcome in review]‐ [name of outcome in study]

  • Surface area of pressure ulcers‐ wound surface area (expressed as cm2)


Time point included in this review: week 5 (end of intervention)
Other time points: baseline and week 3
Notes Withdrawals, (n; reason):

  • Experimental: none

  • Control: none


Funding source: no information about funding source provided
Trial registration or published protocol: no information about trial registration or published protocol provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "…randomly and equally into four groups…" p124
 Comment: insufficient detail reported
Allocation concealment (selection bias) Unclear risk Comment: insufficient detail reported
Blinding of participants (performance bias) 
 All outcomes Low risk Quote: control participants received "Sham HVPC". p125
Blinding of personnel (performance bias) 
 All outcomes Unclear risk Comment: insufficient detail reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "Each ulcer was traced three
 times to establish measurement reliability." p125
 Comment: insufficient detail reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no dropouts
Selective reporting (reporting bias) Low risk Comment: all pre stated outcomes were reported
Other bias Low risk Comment: appears free of other bias