A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
Purpose
The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
Conditions
- Wounds
- Wound of Skin
- Wound Leg
- Venous Leg Ulcer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Signed consent to participate (including consent for digital imaging) - Adult aged ≥18 years - Diagnosed with a chronic, exuding VLU - Exudate amount moderate to large - Wound size from 3 cm2 to 30 cm2, as determined by the clinician - ABPI (within 3 months) > 0.7. If ABPI > 1.4, then big toe pressure > 60 mmHg is required or an alternative measurement verifying normal distal arterial flow - Willing to be compliant with compression therapy
Exclusion Criteria
- Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment - Circumferential wound - Known allergy/hypersensitivity to the materials of the dressing - Use of wound fillers
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- The model is a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic venous leg ulcers over time for 6 weeks according to local standard of care.
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Supportive Care with Non-Bordered Foam Dressing |
All Subjects will use a non-bordered foam dressing as the absorbent primary dressing. |
|
Recruiting Locations
Miami, Florida 33125
Pittsburgh, Pennsylvania 15222
More Details
- Status
- Recruiting
- Sponsor
- Molnlycke Health Care AB
Detailed Description
This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using the non-bordered foam dressing as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. The only included indication is Venous Leg Ulcers (VLU). A total of n=20 participants will be recruited at up to 6 centers within the US and Canada. There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.