Diabetic Foot UlcerNCT06560502
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
A study testing AmnioCore - DFU, Amnio Quad-Core - DFU and Amnio Tri-Core - VLU in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Stability Biologics at 1 site in United States.
Trial summary
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Leg Ulcer, Ulcer Foot
- What is being tested?
- AmnioCore - DFU, Amnio Quad-Core - DFU and Amnio Tri-Core - VLU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to Aug 2026
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects must be at least 21 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement .
- 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
- 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- 6. The target ulcer must be 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.
- 7. The 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; b. TBI ≥ 0.6; c. TCOM ≥ 40 mmHg; d. PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
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- 9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
- 10. The potential subject must consent to using the prescribed offloading method for the duration of the study.
- 11. The potential subject must agree to attend the weekly study visits required by the protocol.
- 12. 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, requires systemic antibiotic therapy, 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 is taking hydroxyurea .
- 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 target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). MolecuLight 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 Target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) 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.
- Women who are pregnant or considering becoming pregnant within the next 6 months.
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
Cutting Edge Research
Circleville, Ohio, 43113
Brock Liden, MD, 614-519-7845
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of DFUs and VLUs.
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.
Read the detailed description
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.
*The initial plan is to evaluate five CAMPs per wound type; however, the modified platform design permits the inclusion of additional CAMPs.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Ulcer Foot, Leg Ulcer
- Being tested
- Standard of Care-DFU, AmnioCore - DFU, Amnio Quad-Core - DFU, Standard of Care-VLU, Amnio Tri-Core - VLU
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Foot Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care-DFUOther
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
AmnioCore - DFUOther
Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Quad-Core - DFUOther
Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Standard of Care-VLUOther
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Tri-Core - VLUOther
Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
AmnioCore ProOther
Participants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amniocore Pro +Other
Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care-DFU | Active comparator | Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Off-loading using the off-loading boot or total contact cast (TCC) provided by SerenaGroup. Receives: Other: Standard of Care-DFU |
| AmnioCore - DFU | Experimental | Dual layer, amniotic membrane allograft. Receives: Other: AmnioCore - DFU |
| Amnio Quad-Core - DFU | Experimental | Four layer, amniotic membrane allograft. Receives: Other: Amnio Quad-Core - DFU |
| Amniocore Pro + - DFU | Experimental | Dual layer, amnion/chorion membrane allograft. Receives: Other: Amniocore Pro + |
| Standard of Care-VLU | Active comparator | Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Compression using multilayer compression wraps provided by SerenaGroup. Receives: Other: Standard of Care-VLU |
| Amnio Tri-Core - VLU | Experimental | Three layer, amniotic membrane allograft. Receives: Other: Amnio Tri-Core - VLU |
| AmnioCore Pro - VLU | Experimental | Three layer, amnion/chorion/amnion membrane allograft. Receives: Other: AmnioCore Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the between-arm difference
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) 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 SOC alone.
Measured: 1-12 Weeks
Percent Area Reduction
To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus SOC alone.
Measured: 1-12 weeks
Change in pain in target ulcer
To determine the between-arm difference in pain for patients that present with a VAS score of greater than 4.
Measured: 1-12 Weeks
Adverse Events
To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus SOC alone.
Measured: 1-14 weeks
Determine improvement in Quality of Life - FWS and determine improvement in Quality of Life - wQOL
To evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) and standard Wound Quality of Life (wQOL) questionnaires at treatment visits 1, 4, 8, and 12.
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 posted19 Aug 2024
- Study start1 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a prospective modified dual platform (matriarch) multicenter randomized controlled clinical trial.
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stability Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560502
- Sponsor's protocol ID
- STABLECAMP
- Status last verified
- Jan 2025
- First submitted
- 15 Aug 2024
- Last updated
- 20 Jan 2025
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of DFUs and VLUs.
- ClinicalTrials.gov ID
- NCT06560502
- Acronym / sponsor ID
- STABLECAMP
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Ulcer Foot, Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Stability BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Aug 2024 (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.
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.
Detailed description
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.
*The initial plan is to evaluate five CAMPs per wound type; however, the modified platform design permits the inclusion of additional CAMPs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- The study design is a prospective modified dual platform (matriarch) multicenter randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care-DFU | Active comparator | Other: Standard of Care-DFUDebridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Off-loading using the off-loading boot or total contact cast (TCC) provided by SerenaGroup. |
| AmnioCore - DFU | Experimental | Other: AmnioCore - DFUDual layer, amniotic membrane allograft. |
| Amnio Quad-Core - DFU | Experimental | Other: Amnio Quad-Core - DFUFour layer, amniotic membrane allograft. |
| Amniocore Pro + - DFU | Experimental | Other: Amniocore Pro +Dual layer, amnion/chorion membrane allograft. |
| Standard of Care-VLU | Active comparator | Other: Standard of Care-VLUDebridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Compression using multilayer compression wraps provided by SerenaGroup. |
| Amnio Tri-Core - VLU | Experimental | Other: Amnio Tri-Core - VLUThree layer, amniotic membrane allograft. |
| AmnioCore Pro - VLU | Experimental | Other: AmnioCore ProThree layer, amnion/chorion/amnion membrane allograft. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Subjects must be at least 21 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement .
- 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
- 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- 6. The target ulcer must be 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.
- 7. The 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:
Key exclusion criteria (14 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, requires systemic antibiotic therapy, 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 |
|---|---|---|
| Standard of Care-DFUBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 13 weeks, whichever occurs first. | Other | Standard of Care-DFU |
| AmnioCore - DFUParticipants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first. | Other | AmnioCore - DFU |
| Amnio Quad-Core - DFUParticipants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first. | Other | Amnio Quad-Core - DFU |
| Standard of Care-VLUBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first. | Other | Standard of Care-VLU |
| Amnio Tri-Core - VLUParticipants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first. | Other | Amnio Tri-Core - VLU |
| AmnioCore ProParticipants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first. | Other | AmnioCore Pro - VLU |
| Amniocore Pro +Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first. | Other | Amniocore Pro + - DFU |
Primary outcome
Determine the between-arm difference
Time frame: 1-12 Weeks
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.
5 secondary outcomes
Time to closure
Time frame: 1-12 Weeks
Percent Area Reduction
Time frame: 1-12 weeks
Change in pain in target ulcer
Time frame: 1-12 Weeks
Adverse Events
Time frame: 1-14 weeks
Determine improvement in Quality of Life - FWS and determine improvement in Quality of Life - wQOL
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 20 Jan 2025.
- 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 study testing AmnioCore - DFU, Amnio Quad-Core - DFU and Amnio Tri-Core - VLU in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Stability Biologics 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 10 inclusion and 14 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 20 Jan 2025. 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.
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 M Rogers (888-960-1343 ext. 1008, brogers@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the between-arm difference (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 20 Jan 2025; AzTrials last refreshed its copy on 27 Oct 2026.