Status:
NOT_YET_RECRUITING
COMS for Chronic Ulcers Treatment
Lead Sponsor:
Sebastian Probst
Collaborating Sponsors:
Medical University of Vienna
University Hospital, Geneva
Conditions:
Venous Leg Ulcer
Wound Heal
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Chronic leg and foot ulcers are defined as wounds that fail to heal in a timely manner, typically persisting for over 4 to 8 weeks without substantial healing despite standard care. These ulcers often...
Detailed Description
Background: Chronic leg and foot ulcers are defined as wounds which fail to proceed through phases of wound healing in an orderly and timely manner to produce a durable structural functional and cosme...
Eligibility Criteria
Inclusion
- Diagnosed leg Ulcer of vascular origin (venous or mixed venous-arterial) without severe arterial insufficiency. Diagnosis of leg ulcer is based on angiological tests carried out at a given time, regardless of whether it is recent or older.
- Ulcer area between 2 - 50 cm2 after debridement
- Patients are older than 18 years of age.
- Chronic ulcer(s) with duration greater than 30 days and less than 2 years (continuous duration)
- If more than one ulcer is present, the target ulcer may be chosen based on the investigator's preference. However, the target ulcer must have a spatial distance of at least 5cm from all other ulcers so that measurements can be carried out accurately even in case an ulcer is growing in size.
- For diabetic patients: well-controlled diabetic mellitus (HbA1c ≤ 8%, historical results \<3 months is acceptable)
- Adequate vascular perfusion as evidence by: ABI \> 0.5 and \< 1.30, ankle artery pressure \>60 mmHg (historical results \<3 months is acceptable).
- Women of childbearing age must agree to use adequate method of contraception
- Informed consent as documented by signature of the participant or a LAR, and being able to understand German or French language and follow the study protocol (cognition)
Exclusion
- Women who are pregnant or breastfeeding (Women of childbearing potential need to perform a pregnancy test (urine test) within 24 hours prior to the study intervention and need at least one simple acceptable contraceptive method)
- Suspected skin cancer, or documented history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
- Use of photosensitizing agents or medications
- The patient is undergoing severe endogenous or drug immunosuppression
- Decompensated heart failure (NYHA III-IV)
- Patient with chronic renal insufficiency currently undergoing dialysis.
- Wounds with \>30% wound area reduction in the last 2 weeks while receiving optimal standard of care (SOC) prior to randomization
- The patient is receiving systemic antibiotic treatment or is receiving/needing antibiotic wound therapy in/near the wound at inclusion
- The patient has received one of the following treatments in the last 2 weeks:
- Arterial interventions such as angioplasty or vascular surgery. Venous Interventions including venous angioplasty, sclerotherapy, stenting, or endovenous thermal or non-thermal ablation.
- Cell and tissue based therapies such as punch \& skin grafts in general, placental based allografts, autologous skin substitutes, cellular and acellular dermal matrix, platelet rich plasma and stem cell therapies
- Advanced wound care therapies such as shock wave, cold plasma, electric stimulation, ultrasound, negative pressure wound therapy, nanotechnologies, oxygen therapies
- Participants that were previously included in this clinical trial
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06528873
Start Date
June 1 2025
End Date
September 30 2026
Last Update
May 14 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.