Viswanathan 2011.
| Methods | RCT; single‐centre, open‐label, phase III, comparative study Setting: Diabetes Research Centre Country: India Duration of follow‐up: 20 weeks Duration of treatment: Not clear Funding source: Cholayil Products and Services, Koyambedu, Chennai, India provided the polyherbal cream with their formulation. Unit of analysis: Participant Participants enrolled between August 2008 and February 2009 |
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| Participants | 40 participants Inclusion criteria: Consecutive Type 2 diabetes patients who presented with an ulcer up to Wagner's grade III classification (grade I, superficial ulcer; grade II, deep ulcer probing to tendon, capsule, or bone; grade III, deep ulcer with abscess, osteomyelitis, or joint sepsis). Exclusion criteria: People who had clinical signs of severe infection; wound that had exposed bone; unwillingness to participate in the study were excluded. Ulcer characteristics at baseline (size of ulcer, number of ulcers, duration of ulceration where reported): "There was no significant difference in the location of the wound between the groups. The distribution of ulcers according to Wagner's grade was also similar in both the study groups. Wagner grade I and II foot ulcers were viable and grade III ulcers were non‐viable tissues" Infection status at baseline: Unclear; severe infections were excluded |
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| Interventions | Group 1 (n = 20): Polyherbal formulation wound cream: Glycyrrhiza glabra, Musa × paradisiaca,Curcuma longa,Pandanus,Aloe vera,Cocos nucifera oil. Group 2 (n = 20): Silver sulphadiazine cream. |
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| Outcomes | Primary review outcomes: Proportion of ulcers healed (partially reported); time to healing (partially reported) Secondary review outcomes: Adverse events |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No information provided. |
| Allocation concealment (selection bias) | Unclear risk | Comment: No information provided. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Not blinded |
| Blinding of outcome assessment (detection bias) Wound healing | Unclear risk | Comment: No information 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 | Comment: Rate of ulcer healing not reported. |
| Selective reporting (reporting bias) | Low risk | Quote: "Of the 40 patients enrolled in this study, 38 adhered to the protocol (group 1; n = 19 and group 2; n = 19). One patient in group 1 was excluded from the study because of severe infection and one patient in group 2 died during the study period (unrelated cause)" |
| Other bias | Low risk | Comment: None noted. |
ITT: intention‐to‐treat PP: per protocol RCT: randomised controlled trial SD: standard deviation