Adunksy 2005.

Methods	Design: 8‐week multicentred, double‐blinded, placebo, randomised controlled study
Participants	Health condition: people with spinal cord injury and advanced age Sample size: Randomisation: at participant level (one ulcer per participant)§ Randomised (participants, n; ulcers, n): 63; 63 Experimental: 35; 35 Control: 28; 28 Analysed (participants, n; ulcers, n): 38; 38 Experimental: 19; 19 Control: 19; 19 Setting, country: Geriatric and Rehabilitation Medicine Departments (11 sites), Israel Inclusion criteria: inpatients over 18 years of age elderly patients and patients with spinal cord injury stage III pressure ulcers (NPUAP scoring system) non‐diabetic ulcers pressure ulcers of more than 30 days but less than 24 months duration pressure ulcers greater than 1 cm2 but smaller than 50 cm2 no prior growth factor or vacuum treatment Exclusion criteria: significant medical disorder impaired liver function enzymes creatinine more than 2 mg% haemoglobin less than 10 g% albumin less than 2.6 g% participants with a pacemaker, taking steroids, chemotherapy, or other immunocompromising drugs Characteristics of pressure ulcer$: Experimental Ulcer duration, mean (SD): 5 days (1) Ulcer stage (%): stage III (100) Control Ulcer duration, mean (SD): 4 days (1) Ulcer stage (%): stage III (100) Overall ulcer location (n): sacrum (25), trochanters (13), heels (6), buttocks (4), ischium (2), calves and ankles (13) Mean age (SD)$: Overall: 71 years (19) Experimental: 72 years (20) Control: 71 years (19) Gender$: Experimental: 46% male Control: 37% male §It is not clearly stated whether participants or pressure ulcers were randomised but the number of pressure ulcers equals the number of participants. $These data were taken from Table 2, p264. The data for the control and experimental groups were not correct. We presumed that the data were swapped by mistake and the numbers in column 3 and 4 were data for the control and experimental groups, respectively.
Interventions	Total groups in this study: two Experimental: active decubitus direct current treatment and conservative treatment Duration: 20 minutes per session; 3 sessions per day; first 2 weeks 20 minutes per session; 2 sessions per day; next 6 weeks Electrode placement: both over the healthy skin surrounding the ulcer Device, manufacturer: Decubitus Direct Current Treatment Device; manufacturer not reported Intensity of ES: not reported Frequency: not applicable (direct current) Type of current: direct Polarity: not reported Control: placebo decubitus direct current treatment and conservative treatment Same settings and duration as experimental group but without current Conservative treatment for both groups Surgical debridement, if deemed necessary followed by application of hydrocolloid or collagen dressings
Outcomes	Outcomes included in this review: presented as [name of outcome in review]‐ [name of outcome in study] Proportion of pressure ulcers healed‐ closure of ulcers (expressed as numbers)* Surface area of pressure ulcers‐ absolute ulcer area (expressed as cm2)** Time to complete healing‐ speed of wound closure (expressed as figure) Complications/adverse events‐ adverse effects (expressed in descriptive format) Not useable data: presented as [name of outcome in review]‐ [name of outcome in study] Rate of pressure ulcer healing‐ speed of healing (expressed as percentage per day)† Time point included in this review: day 57 (end of intervention) *Other time points: baseline and day 147 **Other time points: baseline, day 45, day 57 and day 147 †SD not provided
Notes	Withdrawals, (n; reason): Experimental and Control‐ 25; participants were withdrawn from both groups, 10; due to variety of medical reasons, 15; due to adverse events Funding source: supported by Lifewave Medical Device Company 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)	Low risk	Quote in the published study: "Allocation of the eligible patients to the TG [treatment group] or CG [control group] was randomised in each department by using a block design of size 4, to assure a ratio of 50:50 in the two groups." p263 Comment: insufficient detail reported in the published study but the information about the random generation has been confirmed by one of the authors of the study via email (dated: 1 Feb 2017) and clinical report. Quote in clinical report: “....random number drawn by a computer software.” p18 Reference: Clinical Report‐ Dedicated Computerized Clinical system for Decubitus Direct Current Treatment (DDCT). LifeWave Ltd., Harrison Clinical Research, Medistat Ltd. March 2007
Allocation concealment (selection bias)	Low risk	Quote in published study: "Allocation of the eligible patients to the TG [treatment group] or CG [control group] was randomised in each department…." p263 Comment: insufficient detail reported in the published study but the information about the allocation concealment has been confirmed by one of the authors of the study via email (dated: 1 Feb 2017) and clinical report. Quote in clinical report: “Knowledge of the randomisation list was limited to the persons responsible for creation of the randomisation list, preparation of the random code envelopes....” and “Copies of the complete randomisation list were kept or dispensed in sealed envelopes.” p18 Reference: Clinical Report‐ Dedicated Computerized Clinical system for Decubitus Direct Current Treatment (DDCT). LifeWave Ltd., Harrison Clinical Research, Medistat Ltd. March 2007
Blinding of participants (performance bias) All outcomes	Low risk	Quote: "All…patients were completely blinded to treatment type." p263
Blinding of personnel (performance bias) All outcomes	Low risk	Quote: "All investigators….were completely blinded to treatment type." p263
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote in the published study: "All investigators and patients were completely blinded to treatment type." p263 Comment: not sure if the assessor was one of the investigators, who was blinded to participants’ allocation but the information about the assessor blinding has been confirmed by one of the authors of the study via email (dated: 1 Feb 2017) and clinical report. Quote in clinical report: “Knowledge of the randomisation list was limited to the persons responsible for creation of the randomisation list, preparation of the random code envelopes…...” p18 Reference: Clinical Report‐ Dedicated Computerized Clinical system for Decubitus Direct Current Treatment (DDCT). LifeWave Ltd., Harrison Clinical Research, Medistat Ltd. March 2007
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Thirty‐eight patients completed the trial (54% of TG and 64% of PG)." p266, and also Section 3.5 on adverse effects. Comment: 25/63 (40%) dropouts
Selective reporting (reporting bias)	Low risk	Comment: All pre stated outcomes were reported
Other bias	High risk	Comment: Trial was sponsored by a third party who may have a vested interest in a positive finding. There are discrepancies in the result between the published study and the clinical report.