Khandelwal 2013.

Methods	RCT Setting: Patients were managed initially on inpatient and then on outpatient basis Country: India Duration of follow‐up: Until healing > 8 weeks Duration of treatment: 10 weeks Funding source: Unclear: the study notes that "financial support was provided by dr. Ram Manohar Lohia Hospital, New Dehli" Unit of analysis: Participant
Participants	60 participants Inclusion criteria: Diabetic foot ulcer of at least 8 weeks' duration ‐ stage III and IV, absence of vascular insufficiency involving large‐ and medium‐sized arteries proximal to the ulcer demonstrated by Doppler study, age ≥ 18 years with Type 1 or 2 diabetes. Exclusion criteria: Patients with uncontrolled diabetes, foot ulcer with established gangrene, compromised vascularity of the particular limb, associated osteomyelitis at site of ulcers, pregnant and lactating females, neoplasm at the local site, patients on any immunosuppressive agents, presence of multiple ulcers, patient HIV seropositive, patients with known drug allergy, presence of concomitant life‐threatening infections, chronic renal insufficiency (serum creatinine > 3 mg/dL), when ear cannot equalise the pressure when congested with cold/hay fever, patients with perforation of ear drum. High‐risk case, i.e. bronchial asthma/emphysema Ulcer characteristics at baseline (size of ulcer, number of ulcers, duration of ulceration where reported): Not reported Infection status at baseline: Not reported
Interventions	Group 1: (n = 20) Hyperbaric oxygen therapy. Therapy delivered at 2.5 atmospheres absolute for 60 min per sitting for a total of 30 sittings or until the ulcer had healed. Sittings were distributed over a period of 10 weeks. Patients were given either daily or alternate‐day therapy depending on the availability of slot in the facility. The patients in this group were also debrided from time to time but dressed only with normal saline. No antiseptics were used (group not considered further in review). Group 2: (n = 20) Recombinant human platelet‐derived growth factor. The patients in this group were initially debrided surgically and subsequently as well when required. Group 3: (n = 20) Antiseptic treatments (Edinburgh University Solution of Lime (EUSOL), hydrogen peroxide, and povidone iodine). The foot was soaked in EUSOL for 30 min, followed by use of hydrogen peroxide and povidone iodine (no details about concentration).
Outcomes	Primary review outcome: Proportion of ulcers healed; time to healing (partially reported) Secondary outcomes: None
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: Randomisation methods not specified.
Allocation concealment (selection bias)	Unclear risk	Comment: No information is provided.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study Comment: Blinding unfeasible due to the differences in setting and formulation of the interventions.
Blinding of outcome assessment (detection bias) Wound healing	Unclear risk	Comment: No information is provided.
Blinding of outcome assessment (detection bias) Infection/resolution of infection	Unclear risk	Not relevant
Blinding of outcome assessment (detection bias) Secondary outcomes	Unclear risk	Not relevant
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "6 patients in group 1 (30%), 5 in group 2 (25%) and 1 (5%) in group 3 lost to follow up" Comment: Systematic differences in withdrawal from the study among groups
Selective reporting (reporting bias)	Unclear risk	Comment: The outcomes reported in the results are not the same as specified in the Material and Methods section.
Other bias	Low risk	Comment: None noted.