- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04185558
Safety and Efficacy of ActiGraft Compared to Standard of Care in DFUs
April 10, 2024 updated by: RedDress Ltd.
A Multi Center, Prospective, Randomized, Controlled, Blinded Assessor Trial, Comparing the Safety and Efficacy of ActiGraft to Standard of Care in Patients With Chronic Neuropathic Diabetic Foot Ulcers
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sharon Sirota
- Phone Number: +972545800765
- Email: sharon@reddress.co.il
Study Locations
-
-
-
Germiston, South Africa, 0000
- Wound Care South Africa
-
Tyger Valley, South Africa, 0084
- Eloquent Health & Wellness
-
-
-
-
Alabama
-
Montgomery, Alabama, United States, 36111
- Institute for Advanced Wound Care
-
-
California
-
Los Angeles, California, United States, 90073
- Greater Los Angeles VA
-
Los Angeles, California, United States, 90063
- New Hope Podiatry Group Inc
-
Sylmar, California, United States, 91342
- Olive View UCLA Education & Research Institute
-
-
Florida
-
Miami, Florida, United States, 33175
- Future Health Research Clinic
-
North Miami Beach, Florida, United States, 33169
- Barry University Clinical Research
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
-
Nevada
-
Las Vegas, Nevada, United States, 89148
- Wahab Consulting and Research LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
- Ulcer duration of ≥ 30 days. Time 0 for ulcer duration of ≥ 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all inclusion criteria, including lack of ulcer healing until randomization day.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ActiGraft
Whole blood clot (WBC) gel
|
Whole Blood Clot (WBC) gel
|
Active Comparator: Standard of Care
Alginate dressing, a non-adherent foam dressing, and an outer gauze wrap
|
Alginate dressing, a non-adherent foam dressing, and an outer gauze wrap
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of complete wound closure by 12 weeks
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to complete wound closure
Time Frame: 12 weeks
|
Time to complete wound closure using Cox regression
|
12 weeks
|
Percent area reduction (PAR)
Time Frame: 4 weeks and 8 weeks
|
Percent area reduction (PAR) at 4 and 8 weeks.
|
4 weeks and 8 weeks
|
Nature, frequency, and severity of adverse events in the intent to treat population
Time Frame: 12 weeks
|
Nature, frequency, and severity (by CTCAE5) of adverse events
|
12 weeks
|
Number of patients showing a consistence wound closure post healing determination
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2019
Primary Completion (Actual)
March 31, 2024
Study Completion (Actual)
April 1, 2024
Study Registration Dates
First Submitted
November 12, 2019
First Submitted That Met QC Criteria
December 3, 2019
First Posted (Actual)
December 4, 2019
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 10, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot
-
University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
-
Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
-
Integra LifeSciences CorporationMayo Clinic; Temple University; Samuel Merritt University; New York College of... and other collaboratorsCompletedFoot Ulcers, DiabeticUnited States
-
Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
-
Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
-
Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
-
University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan
-
University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
-
HealthpointCompletedDiabetic Foot Ulcers | Diabetic Foot WoundsUnited States, Canada
-
HealthpointCompleted
Clinical Trials on ActiGraft
-
RedDress Ltd.Recruiting
-
RedDress Ltd.Not yet recruitingDehiscence WoundIsrael
-
RedDress Ltd.RecruitingCutaneous WoundsUnited States