A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTE® in the Treatment of Venous Leg Ulcers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- PolarityTE
- Enrollment
- 29
- Locations
- 4
- Primary Endpoint
- Percentage of index ulcers healed at 12 weeks
Study Overview
Brief Summary
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds
Detailed Description
This study is a prospective, multi-center, Randomized Controlled Trial (RCT) designed to collect patient outcome data on a commercially available human autologous homologous skin construct (SkinTE) with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds (VLU). The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.
There are two arms in the study:
Arm 1: The Experimental Arm , that will include SOC Therapy. SOC therapy in this study is appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and the experimental wound care covering with human autologous,homologous skin construct (SkinTE) followed by a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compression wrap (DynaflexTM or equivalent).
Arm 2: The Standard of Care Arm. The SOC therapy in this study is appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with calcium alginate Fibracol dressing followed by a moisture retentive dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least 18 years old.
- •Presence of a VLU on the leg, below the knee but above the aspect of the medial malleolus, extending at least through the dermis or subcutaneous tissue but not involving tendon, muscle, or bone.
- •The index ulcer will be the largest ulcer if two or more VLUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
- •Index ulcer (i.e. current episode of ulceration) has been present for greater than four weeks prior to the initial screening visit, as of the date subject consents for study.
- •Index ulcer is a minimum of 2.0 cm2 and a maximum of 20 cm2 at first screening visit (SV1) and first treatment visit (TV1).
- •Adequate circulation to the affected extremity as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between ≥ 0.7 and ≤ 1.2 or Arterial Doppler with a minimum of biphasic flow within 3 months of SV1, using the affected study extremity.
- •The index ulcer has been treated with high compression for at least 14 days prior to randomization (30-40 mm Hg).
- •Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
- •Subject understands and is willing to participate in the clinical study and can comply with weekly visits and follow-up regimen.
- •Subject has read and signed the IRB/IEC approved Informed Consent Form before screening procedures have been completed.
- •The index ulcer has a clean granular base, is free of necrotic debris, and appears to be healthy vascularized tissue at time of placement of treatment product.
- •Subject is deemed healthy and stable for treatment based per PI discretion.
Exclusion Criteria
- •Subjects with a BMI ≥45
- •Index ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency.
- •Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
- •Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- •Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit (SV1).
- •History of radiation at the ulcer site (regardless of time since last radiation treatment).
- •Index ulcer has been previously treated or will need to be treated with any prohibited therapies, such as chlorhexidine or collagenase. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
- •Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids > 10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the study.
- •Study ulcer requiring negative pressure wound therapy during the course of the trial.
- •Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
- •Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
- •Subject is pregnant or breast-feeding.
- •Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization.
- •Subjects with end stage renal disease as evidenced by a creatinine greater than 3.0mg/dl within 120 days of randomization.
- •Target wound has presence of local active soft tissue infection involving the treatment site.
- •Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/randomization visit.
- •In the opinion of the Investigator, evidence of unstable human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.
- •Vascular surgery; arterial or venous to the affected extremity within 30 days of screening
Outcomes
Primary Outcomes
Percentage of index ulcers healed at 12 weeks
Time Frame: 12 weeks
examine percent of ulcers healed at week twelve
Secondary Outcomes
- Percentage area reduction at 4 weeks(4 weeks)
- Percentage area reduction at 6 weeks(6 weeks)
- Percentage area reduction at 8 weeks(8 weeks)
- Percentage are reduction at 12 weeks(12 weeks)
- Change in pain levels during trial, using the FACES pain scales which measure pain on a range of 0-10, zero being no pain and 10 being the most severe pain(12 weeks)
- Improvement in quality of life using Wound Quality of Life Score(12 weeks)