Diabetic FootNCT04185558
Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs
A study testing ActiGraft in people with Diabetic Foot and Chronic Ulcer, run by RedDress Ltd. at 16 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Foot, Chronic Ulcer
- What is being tested?
- ActiGraft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 20 Dec 2019to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States12 sites
Boston Medical Center
Boston, Massachusetts, 02118
Eric J Lullove DPM PA
Coconut Creek, Florida, 33073
Pacific Vascular Institute
Hilo, Hawaii, 96720
Wahab Consulting and Research LLC
Las Vegas, Nevada, 89148
New Hope Podiatry Group Inc
Los Angeles, California, 90063
Greater Los Angeles VA
Los Angeles, California, 90073
Future Health Research Clinic
Miami, Florida, 33175
Institute for Advanced Wound Care
Montgomery, Alabama, 36111
Barry University Clinical Research
North Miami Beach, Florida, 33169
Temple University
Philadelphia, Pennsylvania, 19140
Center for Clinical Research Inc
San Francisco, California, 94117
Olive View UCLA Education & Research Institute
Sylmar, California, 91342
South Africa3 sites
Wound Care South Africa
Germiston, 0000
Haute Care
Lyttelton
Eloquent Health & Wellness
Tyger Valley, 0084
About this study
Official title: Multi-Center, Prospective, Randomized, Controlled, Trial, Comparing the Safety and Efficacy of ActiGraft Pro™ 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.
- Conditions
- Diabetic Foot, Chronic Ulcer
- Being tested
- ActiGraft, Standard of Care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiGraftDevice
Whole Blood Clot (WBC) gel
Standard of CareDevice
Alginate dressing, a non-adherent foam dressing, and an outer gauze wrap
| Study group | Role | What they receive |
|---|---|---|
| ActiGraft | Experimental | Whole blood clot (WBC) gel Receives: Device: ActiGraft |
| Standard of Care | Active comparator | Alginate dressing, a non-adherent foam dressing, and an outer gauze wrap Receives: Device: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (4)
Time to complete wound closure
Time to complete wound closure using Cox regression
Measured: 12 weeks
Percent area reduction (PAR)
Percent area reduction (PAR) at 4 and 8 weeks.
Measured: 4 weeks and 8 weeks
Nature, frequency, and severity of adverse events in the intent to treat population
Nature, frequency, and severity (by CTCAE5) of adverse events
Measured: 12 weeks
Number of patients showing a consistence wound closure post healing determination
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start20 Dec 2019
- Primary completion31 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedDress Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185558
- Sponsor's protocol ID
- RD006
- Status last verified
- May 2024
- First submitted
- 12 Nov 2019
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Prospective, Randomized, Controlled, Trial, Comparing the Safety and Efficacy of ActiGraft Pro™ to Standard of Care in Patients With Chronic Neuropathic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04185558
- Acronym / sponsor ID
- RD006
- Conditions
- Diabetic Foot, Chronic Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- RedDress Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ActiGraft | Experimental | Device: ActiGraftWhole blood clot (WBC) gel |
| Standard of Care | Active comparator | Device: Standard of CareAlginate dressing, a non-adherent foam dressing, and an outer gauze wrap |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiGraftWhole Blood Clot (WBC) gel | Device | ActiGraft |
| Standard of CareAlginate dressing, a non-adherent foam dressing, and an outer gauze wrap | Device | Standard of Care |
Primary outcome
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).
4 secondary outcomes
Time to complete wound closure
Time frame: 12 weeks
Percent area reduction (PAR)
Time frame: 4 weeks and 8 weeks
Nature, frequency, and severity of adverse events in the intent to treat population
Time frame: 12 weeks
Number of patients showing a consistence wound closure post healing determination
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiGraft in people with Diabetic Foot and Chronic Ulcer, run by RedDress Ltd. at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, South Africa, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete wound closure by 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.