Diabetic Foot, Venous Leg Ulcer
Conditions
Brief summary
Study is to provide a blinded assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA RCT (WC-22-435).
Detailed description
The purpose of the study is to provide a blinded (treatment arm, timepoint) assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA Randomized Controlled Trial (RCT) (WC-22-435).
Interventions
None listed
Sponsors
ConvaTec Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All subjects from the intention to treat (ITT) population with wound photograph(s) corresponding to the study visit date (WC-22-435) indicating wound closure or their 12-week visit, whichever came first
Exclusion criteria
* Subjects whose photographs are deemed of insufficient quality to make determination of closure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound closure at 12 weeks | 12 week | Incidence of wound closure at 12 weeks, defined as 100% epithelialization of the wound surface, assessed by a blinded observer through photographic evidence |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inter-rater reliability of photographic assessment | up to 12 week | Inter-rater reliability (IRR) of photographic to live assessment of wound closure |
| Inter-rater reliability of photographic site assessment | up to 12 week | IRR of photographic to live assessment of wound closure, by study site |
Countries
Germany
Outcome results
None listed