Evaluating new treatments for nonhealing diabetic foot and venous leg ulcers.

A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.

This study is testing whether new treatments for stubborn diabetic foot and leg ulcers can help people heal better when combined with standard care compared to just standard care alone.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Tiger Biosciences, LLC. (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Monroeville, Pennsylvania)
• Trial ID: NCT06826339 on ClinicalTrials.gov

What this trial studies

This trial aims to compare the effectiveness of several cellular, acellular, and matrix-like products (CAMPs) combined with standard care against standard care alone in treating nonhealing diabetic foot ulcers and venous leg ulcers. It employs a multicenter, prospective, randomized controlled design over a 12-week period to assess the proportion of patients achieving complete ulcer closure. Participants will be monitored for their ulcer healing progress, with specific inclusion criteria regarding ulcer size and duration.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with type 1 or 2 diabetes and specific characteristics of nonhealing diabetic foot or venous leg ulcers.

Not a fit: Patients with ulcers not meeting the size, duration, or location criteria, or those with other complicating health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new effective treatment options for patients suffering from chronic nonhealing ulcers.

How similar studies have performed: Other studies have shown promise in using similar cellular and acellular products for ulcer healing, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:(DFU)

* Subjects The potential subject must be at least 21 years of age or older.
* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
* The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
* The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus.
* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:

  1. ABI between 0.7 and ≤ 1.3;
  2. TBI ≥ 0.6;
  3. TCOM ≥ 40 mmHg;
  4. PVR: biphasic.
* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. The potential subject must have a target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
* The potential subject must consent to using the prescribed offloading method for the duration of the study.
* The potential subject must agree to attend the weekly study visits required by the protocol.
* The potential subject must be willing and able to participate in the informed consent process.

Exclusion Criteria: (DFU)

* The potential subject is known to have a life expectancy of \< 6 months.
* The potential subject's target ulcer is not secondary to diabetes.
* The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
* The potential subject's target ulcer exposes tendon or bone.
* There is evidence of osteomyelitis complicating the potential subject's target ulcer.
* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). EKare Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
* The surface area measurement of the potential subject's target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
* The potential subject has end stage renal disease requiring dialysis.
* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
* A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
* The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
* The potential subject has a wound with active or latent infection.
* The potential subject has a disorder that would create unacceptable risk of post-operative complication.

Inclusion Criteria:(VLU)

* The potential subject must be at least 21 years of age or older.
* At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.
* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
* The potential subject has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:

  1. ABI between 0.7 and ≤ 1.3;
  2. TBI ≥ 0.6;
  3. TCOM ≥ 40 mmHg;
  4. PVR: biphasic.
* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
* The potential subject must agree to attend the weekly study visits required by the protocol.
* The potential subject must be willing and able to participate in the informed consent process.

Exclusion Criteria: (VLU)

* The potential subject is known to have a life expectancy of \< 6 months.
* The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
* The potential subject's target ulcer exposes tendon or bone.
* There is evidence of osteomyelitis complicating the potential subject's target ulcer.
* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). EKare Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
* The surface area measurement of the potential subject's target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
* The potential subject has end stage renal disease requiring dialysis.
* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
* A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
* The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
* The potential subject has a wound with active or latent infection.
* The subject has a disorder that would create unacceptable risk of post-operative complication.

Where this trial is running

Monroeville, Pennsylvania

• Serena Group — Monroeville, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Arshdeep Kaur, MS

Conditions Venous Leg Ulcer; Venous Leg; Diabetic Foot; Diabetic Foot Ulcer; Foot Ulcer, Diabetic; Ulcer Foot; Leg Ulcer; Ulcer Venous