Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care

NCT06564831 | Recruiting

• 1 other identifier: CAMPX
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers

Conditions

Diabetic Foot Ulcer; Diabetic Foot; Foot Ulcer; Ulcer Foot; DFU

Outcome Measures

Primary Outcomes (1)

• The percentage of target ulcers achieving complete wound closure in 12 weeks.

  The percentage of target ulcers achieving complete wound closure in 12 weeks.

  1-12 Weeks

Secondary Outcomes (5)

• The time to heal for target ulcers.

  1-12 weeks

• Wound Area Reduction

  1-12 weeks

• Adverse Events

  1-14 Weeks

• Change in pain in the target ulcer

  1-12 weeks

• Change in quality of life

  1-12 weeks

Other Outcomes (2)

• Percentage of target ulcers achieving complete wound closure

  1-12 weeks

• Changes in chronic inhibitory bacterial load

  1-14 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Other: Standard of Care Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.

Other: SOC

SLAM + SOC

EXPERIMENTAL

Single layer amniotic membrane (SLAM) + SOC

Other: SLAM + SOC

Interventions

SLAM + SOC OTHER

Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

SLAM + SOC

SOC 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

Eligibility Criteria

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

You may qualify if:

• Subjects must be at least 18 years of age or older,
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• At randomization subjects 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.
• The target ulcer must have 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 target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• The target ulcer must be Wager 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.
• The 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 ≥ 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic.

You may not qualify if:

• The subject must consent to using the prescribed off-loading method for the duration of the study.
• The subject must agree to attend the weekly study visits required by the protocol.
• The subject must be willing and able to participate in the informed consent process.
• A subject known to have a life expectancy of \< 6 months is excluded.
• The subject is excluded if the target ulcer is not secondary to diabetes.
• If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
• If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
• A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
• A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• The potential subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
• The subject is excluded if the surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
• The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit during which time the subject received SOC.
• A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.

Sponsors & Collaborators

• Applied Biologics, LLC: lead
• SerenaGroup, Inc.: collaborator

Study Sites (1)

Detroit Foot and Ankle

Clinton Township, Michigan, 48038, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases

Central Study Contacts

Bennett Rogers

CONTACT

888-960-1343; brogers@serenagroups.com

Thomas Serena

CONTACT

814-688-4000; serena@serenagroups.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 21, 2024
• Study Start: September 20, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)