Diabetic Foot UlcerPhase 4RENEWNCT07086443
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
A Phase 4 study testing Activate™ Matrix, AmnioDefend™ FT Matrix and Palisade™ DM Matrix in people with Diabetic Foot Ulcer and DFU, run by Sequence LifeScience, Inc. at 1 site in United States.
Trial summary
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, DFU, Diabetic Foot Ulcer (DFU)
- What is being tested?
- Activate™ Matrix, AmnioDefend™ FT Matrix and Palisade™ DM Matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to Jul 2027
- Phase
- Phase 4
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The potential subject must be at least 18 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the imaging device length times width.
- The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
- The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
- The potential subject must have a target ulcer that is Wagner 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.
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- The potential subject's 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 between 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- The potential subject must have a target ulcer located on the 50% below the malleolus and not on the dorsal toes.
- The ulcer must be offloaded for at least 14 days prior to enrollment.
- The potential subject must consent to using the prescribed offloading method for the duration of the study.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process.
Who cannot join
- The potential subject is known to have a life expectancy of < 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
- The target ulcer is infected or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
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- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
- The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.
- The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
- The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition.
- The potential subject has a known allergy or sensitivity to PBS, IPA, processing solutions, reagents, or latex.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Serena Group- Monroeville
Monroeville, Pennsylvania, 15146
Laura Serena, lserena@serenagorups.com
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the Treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Read the detailed description
This study is a prospective modified platform multicenter randomized controlled clinical trial. The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
- Conditions
- Diabetic Foot Ulcer, DFU, Diabetic Foot Ulcer (DFU), Foot Ulcer Due to Type 1 Diabetes Mellitus, Foot Ulcer Due to Type 2 Diabetes Mellitus, Ulcer
- Being tested
- Activate™ Matrix, AmnioDefend™ FT Matrix, Palisade™ DM Matrix, Enclose™ TL Matrix, Sentry™ SL Matrix
- Medical subject headings
- Diabetic Foot, Ulcer, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activate™ MatrixOther
Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AmnioDefend™ FT MatrixOther
Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Palisade™ DM MatrixOther
Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Enclose™ TL MatrixOther
Participants will receive weekly applications of Enclose™ TL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sentry™ SL MatrixOther
Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Shelter™ DM Matrix + SOCOther
Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Activate™ Matrix +SOC | Experimental | Three layers: amnion, intermediate layer, and chorion Receives: Other: Activate™ Matrix |
| AmnioDefend™ FT Matrix +SOC | Experimental | Three layers: amnion, intermediate layer, and chorion Receives: Other: AmnioDefend™ FT Matrix |
| Palisade™ DM Matrix +SOC | Experimental | Two layers: amnion and chorion Receives: Other: Palisade™ DM Matrix |
| Enclose™ TL Matrix +SOC | Experimental | Three layers: amnion, chorion, amnion Receives: Other: Enclose™ TL Matrix |
| Sentry™ SL Matrix +SOC | Experimental | One layer: amnion Receives: Other: Sentry™ SL Matrix |
| Shelter™ DM Matrix +SOC | Experimental | Two layers: amnion and chorion Receives: Other: Shelter™ DM Matrix + SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-arm difference in subjects achieving complete closure
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Measured: 1-12 Weeks
Secondary outcomes (5)
Time to closure
To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus matched control subjects.
Measured: 1-12 weeks
Percentage area reduction rate
To determine the between-arm difference in percent area reduction (PAR) at weekly intervals for CAMP plus SOC versus matched control subjects.
Measured: 1-12 weeks
Adverse Events
To determine the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus matched control subjects.
Measured: 1-12 Weeks
Determine quality of life
To determine the between-arm difference in quality of life for subjects receiving CAMP plus SOC versus matched control subjects using the Forgotten Wound Score (FWS). The FWS is scored on a scale of 0-4. 0 being never and 4 being mostly.
Measured: 1-12 weeks
Determine Quality of Life
To determine the between-arm difference in quality of life for subjects receiving CAMP plus SOC versus matched control subjects Wound Quality of Life (wQOL) questionnaires. WQOL is scored 0-5. 0 being never and 5 being very much.
Measured: 1-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start11 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multi-center, prospective, matched control clinical study trial evaluating placental derived allografts and standard of care versus standard of care alone in the treatment of nonhealing diabetic foot ulcers. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of seven CAMPs plus SOC for 12 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only the secondary dressing in the CAMP arm. The study utilizes a modified platform design adopted from clinical trials developed during the pandemic to simultaneously test multiple interventions in a single trial.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequence LifeScience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086443
- Sponsor's protocol ID
- RENEW
- Acronym
- RENEW
- Status last verified
- May 2026
- First submitted
- 11 Jul 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No