Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs

NCT ID: NCT04185558

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-20
• Study Completion Date: 2024-04-01

Brief Summary

• The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers.
• The subjects are randomized to receive 1 of 2 treatments, either with ActiGraft and standard of care (SOC) or with SOC alone.
• The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of the ActiGraft + SOC or SOC until for up to 12 weeks or until the study ulcer has completely healed (i.e., 100% closure as assessed by the Investigator and blinded assessor and confirmed 2 weeks later at the healing confirmation visit (HCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the ActiGraft arm or (2) change the standard of care dressing in the control arm.
• Immediately after the study ulcer is confirmed as completely healed, subjects will enter the 12-week Follow-up Phase. During the Follow-Up phase, subjects will be evaluated twice during the first month and then monthly for two additional visits every 4 weeks until the completion of the 12-week Follow-up Phase.

Conditions

Diabetic Foot; Chronic Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ActiGraft

Whole blood clot (WBC) gel

Group Type: EXPERIMENTAL

ActiGraft

Intervention Type: DEVICE

Whole Blood Clot (WBC) gel

Standard of Care

Alginate dressing, a non-adherent foam dressing, and an outer gauze wrap

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DEVICE

Alginate dressing, a non-adherent foam dressing, and an outer gauze wrap

Interventions

ActiGraft

Whole Blood Clot (WBC) gel

Intervention Type: DEVICE

Standard of Care

Alginate dressing, a non-adherent foam dressing, and an outer gauze wrap

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject is ≥19 years of age and has type 1 or 2 diabetes
• Chronic neuropathic DFU, located distal to the malleolus (excluding ulcers between the toes but including those of the heel) and depth ≤ 5 mm with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts (Minor tunneling and undermining will be included).
• Ulcer size between 1 cm2 and 28 cm2 (post-debridement).
• For subjects with potentially multiple eligible DFUs, the largest non-healing wound will be selected.
• Study ulcer separated from other ulcers by at least 1 cm.
• Ulcer or affected limb free of clinical signs of infection.
• Post-debridement, ulcer free of necrotic tissue.
• Adequate circulation to the affected extremity as demonstrated by at least one of the following: (1) Transcutaneous oxygen test (TcPO2) ≥ 30 mm Hg,; (2) Ankle Brachial Index (ABI) between 0.7 and 1.2; (3)Triphasic or biphasic Doppler arterial waveforms at the ankle of affected leg; (4) Toe Brachial Index > 0.6
• HbA1c ≤ 12.0%
• Demonstrated adequate offloading regimen.
• Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft.
• Female subjects who are capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to participate in the study

Exclusion Criteria

• Ulcer not of neuropathic diabetic foot pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, or arterial etiology, or pressure ulcers.).
• Known or suspected ulcer malignancy of the index ulcer.
• Active Charcot of the affected foot
• Presence of underlying osteomyelitis.
• Subject with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection.
• History of alcohol or substance abuse, within the previous 2 months
• Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug or treatment within 30 days of randomization visit.
• Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect the rate and quality of, wound healing (e.g., systemic steroids (more than 10mg per day), immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the foot, planned vascular surgery on the study ulcer limb on the 90 days from screening, angioplasty or thrombolysis, chemotherapy).
• Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization or is scheduled to receive during the study.
• Subject has been treated with hyperbaric oxygen within 5 days of screening or is scheduled to receive during the study.
• Wound on a subject who has a life expectancy of less than 12 months.
• Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form.
• Cannot withdraw blood in the required amount (up to 15 mL per week) technically.
• Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking coumadin, aspirin, Plavix (clopidogrel), Eliquis or Pradaxa will not be excluded.
• Hemoglobin anemia (< 9 g/dL).
• Subject has a history of or any of the following intercurrent illnesses or conditions that would compromise the safety of the subject, or the normal wound healing process: (1) End stage renal disease; (2)Immunosuppression; (3) Severe malnutrition; (4) Liver disease; (5) Scleroderma; (6) Acquired immune deficiency disease (AIDS) or HIV positive; (7) Active connective tissue disorder; (8)Exacerbation of sickle cell anemia
• If ulcer area decreases by ≥ 30% during the initial 2-week screening (± 2 days) and standard of care phase, subject will be excluded.
• Women who are pregnant or currently breast feeding.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RedDress Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute for Advanced Wound Care

Montgomery, Alabama, United States

New Hope Podiatry Group Inc

Los Angeles, California, United States

Greater Los Angeles VA

Los Angeles, California, United States

Center for Clinical Research Inc

San Francisco, California, United States

Olive View UCLA Education & Research Institute

Sylmar, California, United States

Eric J Lullove DPM PA

Coconut Creek, Florida, United States

Future Health Research Clinic

Miami, Florida, United States

Barry University Clinical Research

North Miami Beach, Florida, United States

Pacific Vascular Institute

Hilo, Hawaii, United States

Boston Medical Center

Boston, Massachusetts, United States

Wahab Consulting and Research LLC

Las Vegas, Nevada, United States

Temple University

Philadelphia, Pennsylvania, United States

Wound Care South Africa

Germiston, , South Africa

Haute Care

Lyttelton, , South Africa

Eloquent Health & Wellness

Tyger Valley, , South Africa

Acinadem Altunizade

Istanbul, , Turkey (Türkiye)

Countries

United States; South Africa; Turkey (Türkiye)

Other Identifiers

RD006

Identifier Type: -

Identifier Source: org_study_id