COMS for Chronic Ulcers Treatment

Launched by SEBASTIAN PROBST · Jul 26, 2024

Keywords

ClinConnect Summary

The COMS for Chronic Ulcers Treatment trial is studying a new therapy for chronic leg and foot ulcers that don’t heal properly, even with standard care. These ulcers are often caused by problems with blood flow, leading to inflammation and infections that prevent healing. This trial aims to see if a combination of a new treatment called Concurrent Optical and Magnetic Stimulation (COMS) with regular care can help improve healing, reduce pain, and enhance the quality of life for patients with venous leg ulcers.

To participate in this trial, you need to be over 18 years old and have a chronic ulcer that has lasted for more than 30 days but less than 2 years. The ulcer should be of vascular origin, meaning it’s related to blood flow issues. Participants must also have adequate blood flow as shown by specific tests. During the study, participants will receive the COMS therapy or standard care alone, and they will be monitored for healing progress and other outcomes. This trial is not yet recruiting participants, but it offers a new hope for those struggling with chronic ulcers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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