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

NCT04185558 | Completed DMC FDA Device

• 1 other identifier: RD006
• Study Type: interventional
• Target: 119
• Locations: 3 countries
• Sites: 16

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

Outcome Measures

Primary Outcomes (1)

• Incidence of complete wound closure by 12 weeks

  Incidence of complete wound closure by 12 weeks using chi square (two-sided; alpha set at .05 level of significance), or Fischer exact test if one group has ≤ 5 completely closed wounds. Analysis will be adjusted using generalized linear modeling (logit function).

  12 weeks

Secondary Outcomes (4)

• Time to complete wound closure

  12 weeks

• Percent area reduction (PAR)

  4 weeks and 8 weeks

• Nature, frequency, and severity of adverse events in the intent to treat population

  12 weeks

• Number of patients showing a consistence wound closure post healing determination

  24 weeks

Study Arms (2)

ActiGraft

EXPERIMENTAL

Whole blood clot (WBC) gel

Device: ActiGraft

Standard of Care

ACTIVE COMPARATOR

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

Device: Standard of Care

Interventions

ActiGraft DEVICE

Whole Blood Clot (WBC) gel

ActiGraft

Standard of Care DEVICE

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

Standard of Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• RedDress Ltd.: lead

Study Sites (16)

Institute for Advanced Wound Care

Montgomery, Alabama, 36111, United States

Location

New Hope Podiatry Group Inc

Los Angeles, California, 90063, United States

Location

Greater Los Angeles VA

Los Angeles, California, 90073, United States

Location

Center for Clinical Research Inc

San Francisco, California, 94117, United States

Location

Olive View UCLA Education & Research Institute

Sylmar, California, 91342, United States

Location

Eric J Lullove DPM PA

Coconut Creek, Florida, 33073, United States

Location

Future Health Research Clinic

Miami, Florida, 33175, United States

Location

Barry University Clinical Research

North Miami Beach, Florida, 33169, United States

Location

Pacific Vascular Institute

Hilo, Hawaii, 96720, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Wahab Consulting and Research LLC

Las Vegas, Nevada, 89148, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Wound Care South Africa

Germiston, 0000, South Africa

Location

Haute Care

Lyttelton, South Africa

Location

Eloquent Health & Wellness

Tyger Valley, 0084, South Africa

Location

Acinadem Altunizade

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 4, 2019
• Study Start: December 20, 2019
• Primary Completion: March 31, 2024
• Study Completion: April 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); ZA (3); TU (1)