Status:
COMPLETED
FORCEREPAIR - A Wound Exudate Investigation
Lead Sponsor:
Bispebjerg Hospital
Collaborating Sponsors:
Akribes Biomedical GmbH
Vascular Research Unit and Department of Vascular Surgery
Conditions:
Venous Leg Ulcer
Wound Healing
Eligibility:
All Genders
18+ years
Brief Summary
The observational longitudinal study will collect wound exudate from twenty patients with venous leg ulcers. Wound exudate samples are collected using twenty-four-hour collection with polyurethane foa...
Detailed Description
This dual centre longitudinal observational study will run from January 2024 to January 2025. The investigation will include twenty patients over four weeks including four study visits. Sampling of wo...
Eligibility Criteria
Inclusion
- Adults fulfilling all inclusion criteria
- Age \>18 years
- Venous leg ulcer diagnosis and classic characteristics (localisation, varicose veins, brown-orange hyperpigmentation, leg oedema, stasis dermatitis, atrophie blanche or lipodermatosclerosis) verified by a wound expert (if in doubt venous doppler will be used for verification)
- Wound Area equal to or above 1 cm2 (measured with a ruler length x width)
- Patient can understand Danish
- Patient can comply with protocol
- Patient is fully informed about the study and has given informed consent
Exclusion
- Venous leg ulcer with communication to bone
- Known or suspected cancer in the wound
- Allergies towards products used in the study, e.g. polyurethane foam and tegaderm
- Dementia
- Judgement by the investigator that the patient is not suited for study participation
Key Trial Info
Start Date :
January 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT06109844
Start Date
January 24 2024
End Date
October 1 2025
Last Update
December 16 2025
Active Locations (2)
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1
Danish Wound Healing Center, Bispebjerg Hospital
Copenhagen, Northwest, Denmark, 2400
2
Vascular Research Unit and Department of Vascular Surgery, Viborg Regional Hospital
Viborg, Denmark, 8800