| Methods |
Design: three group parallel trial
Purpose: examine the effect of Essaven gel in patients with venous microangiopathy and venous ulceration |
| Participants |
Patients: out‐patients with microangiopathy and venous ulcers
Baseline comparability: yes (age, gender ratio) |
| Interventions |
Placebo: Gel not containing Essaven
Untreated: no gel
Experimental: Gel containing Essaven
(Co‐intervention: elastic stockings) |
| Outcomes |
Ulcer healing rates
Total symptom score (based on Pain, edema, alternation in social life and working handicaps, cost of care, deambulation)
Microcirculatory parameters (flux, CO2, O2) |
| Notes |
No patient in either group had healed ulcers. For computing reasons we have entered data as one patient in each group had a healed ulcer. |
| 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 |
'Operators were unaware of the contents of the tube, which was numbered' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| 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 |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
High risk |
N = 19 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
