| Methods |
Design: three group parallel trial
Purpose: to evaluate the effect of local (foot) treatment with Essaven gel in subjects with diabetes mellitus and neuropathy without ulcers. |
| Participants |
Patients: out‐patients with diabetes mellitus and neuropathy without ulcers.
Baseline comparability: NS |
| Interventions |
Placebo: Placebo‐gel
Untreated: No‐treatment
Experimental: 1g of Essaven gel applied to foot
(Co‐intervention: Standard insulin management) |
| Outcomes |
Laser Doppler flowmetry measuring flux
PO2/PCO2 (Kontron analyzer with a Combi sensor) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Low risk |
'the randomization process was controlled by an external statistical controller according to GCP rules' |
| Blinding?
Treatment provider |
Low risk |
'The trial was a double‐blind, placebo‐controlled study' |
| Blinding?
Outcome assessor |
Low risk |
Objective measurements of flux and PO2/PCO2
|
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
High risk |
N = 23 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
