Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs

NCT06674980 | Recruiting

• 1 other identifier: Pro00082457
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.

Conditions

Pathologic Processes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Disease; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Diabetes Mellitus, Type 2; Ulcer; Foot Ulcer Unhealed

Keywords

Human Placental Membrane (HPM); Diabetic Foot Ulcer (DFU); Venous Leg Ulcer (VLU); Cellular, Acellular, and Matrix-like Product (CAMP); Cellular and/or Tissue-Based Product (CTP)

Outcome Measures

Primary Outcomes (1)

• Determine the percentage of subjects achieving complete closure of target ulcer over 12 weeks.

  The proportion of subjects achieving complete wound closure of target ulcer.

  1-12 weeks

Secondary Outcomes (5)

• Time to closure for target ulcer.

  1-12 weeks

• Percent Area Reduction (PAR)

  1-12 weeks

• Adverse Events

  1-12 weeks

• Change in pain in target ulcer

  1-12 weeks

• Determine improvement in quality of life

  1-12 weeks

Study Arms (6)

Standard of Care - DFU

ACTIVE COMPARATOR

Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC).

Other: Standard of Care - DFU

AM/Single - DFU

EXPERIMENTAL

AM/Single is an air-dried, sterile single layer human amniotic membrane allograft.

Other: AM/Single - DFU

AM/Double - DFU

EXPERIMENTAL

AM/Double is an air-dried, sterile double layer human amniotic membrane allograft.

Other: AM/Double - DFU

Standard of Care - VLU

ACTIVE COMPARATOR

Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps.

Other: Standard of Care - VLU

AM/Single - VLU

EXPERIMENTAL

AM/Single is an air-dried, sterile single layer human amniotic membrane allograft.

Other: AM/Single - VLU

AM/Double - VLU

EXPERIMENTAL

AM/Double is an air-dried, sterile double layer human amniotic membrane allograft.

Other: AM/Double - VLU

Interventions

Standard of Care - DFU OTHER

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Standard of Care - DFU

AM/Single - DFU OTHER

Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

AM/Single - DFU

AM/Double - DFU OTHER

Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

AM/Double - DFU

Standard of Care - VLU OTHER

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Standard of Care - VLU

AM/Single - VLU OTHER

Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

AM/Single - VLU

AM/Double - VLU OTHER

Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

AM/Double - VLU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age or older.
• Must have diagnosis of type 1 or 2 Diabetes mellitus.
• At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.
• Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.
• Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
• 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 ulcer may not include exposed tendon or bone.
• 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:
• ABI between 0.7 and \<= 1.3
• TBI \>= 0.6
• TCOM \>= 40 mmHg
• PVR: biphasic

You may not qualify if:

• Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.
• Subject must consent to using the prescribed offloading method for the duration of the study.
• Subject must agree to attend weekly study visits.
• Subject must be willing and able to participate in the consent process.
• Subject is known to have a life expectancy of \< 6 months.
• Subject's target ulcer is not secondary to diabetes.
• Target ulcer is infected or there is cellulitis in the surrounding skin.
• Target ulcer exposes tendon or bone.
• Evidence of osteomyelitis complicating the target ulcer.
• Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• The 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).
• Subject is taking hydroxyurea.
• Subject has applied topical steroids to the ulcer surface within one month of initial screening.
• Subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
• Subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.

Sponsors & Collaborators

• C5 Biomedical: lead
• SerenaGroup, Inc.: collaborator

Study Sites (1)

Poirot Podiatry

Metairie, Louisiana, 70001, United States

RECRUITING

MeSH Terms

Conditions

Pathologic Processes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Diabetes Mellitus, Type 2; Ulcer; Varicose Ulcer

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Diseases; Varicose Veins

Study Officials

• Thomas Serena, MD

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bennett Rogers

CONTACT

888-960-1343; Brogers@serenagroups.com

Connie Chung, PhD

CONTACT

734-730-3058; Connie@c5biomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In addition to the principal investigator's determination of complete closure an independent assessment of the primary endpoint will be performed. Two wound care specialists not associated with the trial ("The Reviewers") will review the digital images of ulcers that have healed. They will review the closed visit and the closure confirmation visit. Deidentified digital images taken with the imaging device will be provided to the reviewers. Two reviewers will assess each photograph and be blinded to the arm in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): November 22, 2026
• Study Completion (Estimated): January 22, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)