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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07086443
- Acronym / sponsor ID
- RENEW / RENEW
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Sequence LifeScience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Jul 2025 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Activate™ Matrix +SOC | Experimental | Other: Activate™ MatrixThree layers: amnion, intermediate layer, and chorion |
| AmnioDefend™ FT Matrix +SOC | Experimental | Other: AmnioDefend™ FT MatrixThree layers: amnion, intermediate layer, and chorion |
| Palisade™ DM Matrix +SOC | Experimental | Other: Palisade™ DM MatrixTwo layers: amnion and chorion |
| Enclose™ TL Matrix +SOC | Experimental | Other: Enclose™ TL MatrixThree layers: amnion, chorion, amnion |
| Sentry™ SL Matrix +SOC | Experimental | Other: Sentry™ SL MatrixOne layer: amnion |
| Shelter™ DM Matrix +SOC | Experimental | Other: Shelter™ DM Matrix + SOCTwo layers: amnion and chorion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| Activate™ MatrixParticipants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Activate™ Matrix +SOC |
| AmnioDefend™ FT MatrixParticipants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | AmnioDefend™ FT Matrix +SOC |
| Palisade™ DM MatrixParticipants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Palisade™ DM Matrix +SOC |
| Enclose™ TL MatrixParticipants will receive weekly applications of Enclose™ TL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Enclose™ TL Matrix +SOC |
| Sentry™ SL MatrixParticipants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Sentry™ SL Matrix +SOC |
| Shelter™ DM Matrix + SOCParticipants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Shelter™ DM Matrix +SOC |
Primary outcome
Between-arm difference in subjects achieving complete closure
Time frame: 1-12 Weeks
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.
5 secondary outcomes
Time to closure
Time frame: 1-12 weeks
Percentage area reduction rate
Time frame: 1-12 weeks
Adverse Events
Time frame: 1-12 Weeks
Determine quality of life
Time frame: 1-12 weeks
Determine Quality of Life
Time frame: 1-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 16 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bennett Sarver (1-833-865-6300, info@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-arm difference in subjects achieving complete closure (time frame: 1-12 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 19 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.