Clinical trial NCT05608317: A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
Official title: A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Venous Leg Ulcers Using a Non-Bordered Foam Dressing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wounds
Wound of Skin
Wound Leg
Venous Leg Ulcer
Keywords: Venous Leg Ulcer
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2022-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wound progress of the total effect of treatment using ALLEVYN Non-Adhesive
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Secondary outcomes:
measure: Percentage wound area reduction over time
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Linear wound healing over time
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Change in granulation tissue over time
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Change in sloughy tissue over time
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Change in exudate amount over time
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Change in exudate nature over time
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Change in peri-wound skin condition over time
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Change in maceration over time
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Wound/Peri-Wound itch score prior to dressing removal over time (PRO)
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Wound pain score during dressing wear over time (PRO)
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Wound pain score related to removal of dressing over time (PRO)
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Trauma to the wound/peri-wound during dressing removal over time
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Primary dressing's ability to be comfortable to wear (PRO)
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Dressing's ability to be comfortable to wear with compression (PRO)
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Evaluation of Wound Quality of Life (QoL) (PRO)
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Technical Performance (Investigator/designee's evaluation)
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Status of dressing during a routine dressing change or complication
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Pre-compression edema
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Compression removed/changed/applied
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Compliance with compression
timeFrame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Wear time (days)
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Debridement performed
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Cleansing performed
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
measure: Evaluation of all reported adverse events and device deficiencies
timeFrame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Center for Clinical Trials, Inc.
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Pittsburgh
country: United States
facility: Serena Group Research Institute
state: Pennsylvania
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD, MAS
role: PRINCIPAL_INVESTIGATOR
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