Kloth 1988.

Methods	Design: prospective randomised controlled study
Participants	Health condition: people with ulcers Sample size: Randomisation: at participant level (one ulcer per participant)§ Randomised (participants, n; ulcers, n): 16; 16 Experimental: 9; 9 Control: 7; 7 Analysed (participants, n; ulcers, n): 16; 16 Experimental: 9; 9 Control: 7; 7 Setting, country: Marquett University Hospital (1 site), USA Inclusion criteria: patients with intact peripheral nervous system patients with stage IV decubitus ulcers Exclusion criteria: not reported Characteristics of pressure ulcer: Experimental Ulcer aetiology (n): cerebrovascular accident (2), peripheral vascular disease (2), lower extremity fracture (1), pilonidal cyst (1), above knee amputation (1), diabetic‐fracture (2) Ulcer duration: between 1 month and 2.5 years Ulcer location: not reported Ulcer stage (%): stage IV (100) Control Ulcer aetiology (n): cerebrovascular accident (2), anaemia (1), senile dementia (1), pilonidal cyst (1), stasis ulcer (1), diabetes‐fracture (1) Ulcer duration: between 1 month and 2.5 years Ulcer location: not reported Ulcer stage (%): stage IV (100) Mean age (SD): Experimental group: 71 years (21) Control group: 66 years (21) Gender: not reported §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: two Experimental: treatment group and standard care Duration: 45 minutes per session; 1 session per day; 5 days a week; until healed Electrode placement: one over the ulcer and the other on the healthy skin 15 cm away Device, manufacturer: DynaWave Model 12, DynaWave, USA Intensity of ES: visible muscle contraction Frequency: 105 Hz Type of current: pulsed Polarity: positive over the wound ‐ until the patient reached ulcer healing plateau if plateau, negative over ulcer Control: control group and standard care Sham with no ES delivered Standard care for both groups All patients took high‐protein dietary supplement. Debridement was performed manually and with enzymes.
Outcomes	Not useable data*: presented as [name of outcome in review]‐ [name of outcome in study] Surface area of pressure ulcers ‐ wound area (expressed as cm2) Rate of pressure ulcer healing ‐ healing rate (expressed as percentage per week) Time point of outcome measures: baseline and until healed *Individual data are presented but at different time since randomisation. The data are therefore not comparable.
Notes	Withdrawals, (n; reason): Experimental: none Control: none Funding source: the equipment used in this study was provided by DynaWave Corp. Trial registration or published protocol: insufficient detail reported in the study but an author of this study confirmed that they did not publish a study protocol in a journal or on a trial registry (email dated: 31 January 2017)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "..tossed a coin…" p504
Allocation concealment (selection bias)	Low risk	Comment: insufficient detail reported in the study but an author confirmed that the allocation of participants was determined by drawing of random number by a person not involved in the study (email dated: 31 January 2017)
Blinding of participants (performance bias) All outcomes	Low risk	Quote: control participants received "sham treatment". p504
Blinding of personnel (performance bias) All outcomes	Low risk	Comment: insufficient detail reported in the study but an author confirmed that the therapists delivering the intervention were blinded to group allocation (email dated: 31 January 2017)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The same physical therapist (J.A.F.) recorded surface area wound dimensions for each patient before treatment and at weekly treatment intervals." p506 Comment: insufficient detail reported in the study but an author confirmed that the assessors were blinded (email dated: 31‐Jan‐2017)
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	High risk	Comment: Two control group participants were moved across to experimental group Trial was sponsored by a third party who was likely to have a vested interest in a positive finding