NCT07308678

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

December 17, 2025

Last Update Submit

January 6, 2026

Conditions

Venous Leg UlcerDiabetic Foot

Outcome Measures

Primary Outcomes (1)

  • Wound closure at 12 weeks

    Incidence of wound closure at 12 weeks, defined as 100% epithelialization of the wound surface, assessed by a blinded observer through photographic evidence

    12 week

Other Outcomes (2)

  • Inter-rater reliability of photographic assessment

    up to 12 week

  • Inter-rater reliability of photographic site assessment

    up to 12 week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who have wound photographs of sufficient quality taken as per standard of care (SOC) during the AAA RCT (WC-22-435) that correspond to wound closure or their 12-week visit.

You may qualify if:

  • 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

You may not qualify if:

  • Subjects whose photographs are deemed of insufficient quality to make determination of closure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essen University Hospital

Essen, Germany

Location

MeSH Terms

Conditions

Varicose UlcerDiabetic Foot

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetic AngiopathiesFoot UlcerDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Joachim Dissemond, MD

    Essen University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 30, 2025

Study Start

April 22, 2025

Primary Completion

May 28, 2025

Study Completion

May 28, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations

DE(1)