Investigation of Wound Exudate in Patients with Venous Leg Ulcers
FORCEREPAIR - A Wound Exudate Investigation
This study is trying to collect and analyze fluid from the wounds of people with venous leg ulcers to better understand their healing and the bacteria involved.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 2 sites (Copenhagen, Northwest and 1 other locations) |
| Trial ID | NCT06109844 on ClinicalTrials.gov |
What this trial studies
This observational longitudinal study aims to collect wound exudate from twenty patients diagnosed with venous leg ulcers over a four-week period. Patients will undergo four study visits where wound exudate samples will be collected using various methods, including polyurethane foam and the NovaSwab technique. The study will also assess the wound bacteria microbiome and monitor wound size using advanced planimetric tools. Standard wound care will be provided, and a biobank will be established for future research with leftover samples.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with a confirmed diagnosis of venous leg ulcers meeting specific clinical criteria.
Not a fit: Patients with venous leg ulcers that communicate with bone or have known or suspected cancer in the wound may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of wound healing processes and improve treatment strategies for venous leg ulcers.
How similar studies have performed: While this study employs established methods, the specific focus on wound exudate in venous leg ulcers is relatively novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Copenhagen, Northwest and 1 other locations
- Danish Wound Healing Center, Bispebjerg Hospital — Copenhagen, Northwest, Denmark (Recruiting)
- Vascular Research Unit and Department of Vascular Surgery, Viborg Regional Hospital — Viborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Frederik Plum, MD — Bispebjerg Hospital
- Study coordinator: Frederik Plum, MD
- Email: frederik6@hotmail.com
- Phone: +4529671247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.