Diabetic Foot Ulcer (DFU)CAMPSTIMNCT06449638
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
A study testing Revita, Relese and Cogenex in people with Diabetic Foot Ulcer (DFU) and Ulcer Foot, run by StimLabs at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Ulcer Foot, Diabetic Foot
- What is being tested?
- Revita, Relese and Cogenex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Jul 2024to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age or older.
- Diagnosis of type 1 or 2 Diabetes mellitus.
- At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
- 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.
- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- The target ulcer must be full thickness without exposed bone.
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- 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:
- Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;
- Toe-Brachial Index (TBI) ≥ 0.6;
- Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;
- Pulse Volume Resistance (PVR): biphasic.
- 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.
- Target ulcers located on the plantar aspect of the foot 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.
- There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
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- 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).
- 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 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.
- Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
- The potential subject has end stage renal disease requiring dialysis.
- Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
- A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The target ulcer 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 indicator score <17 as measured on the Mini Nutrition Assessment.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
SerenaGroup Research South
Jefferson Hills, Pennsylvania, 15025
Kristy Breisinger, 888-960-1343 ext. 1010, kbreisinger@serenagroups.com
- Not yet recruiting
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
Nicole Schrecengost, 724-664-3843, nschrecengost@serenagroups.com
- Recruiting
SerenaGroup Monroeville
Monroeville, Pennsylvania, 15146
Kristy Breisinger, 888-960-1343 ext. 1010, kbreisinger@serenagroups.com
Thomas Serena, MD
- Recruiting
SerenaGroup Omaha Research Center
Omaha, Nebraska, 68114
Bennett Rogers, 888-960-1343 ext. 1008, brogers@serenagroups.com
- Recruiting
Wound Care of Tulsa
Tulsa, Oklahoma, 74135
Linda Le, 918-561-6661, linda@tulsawoundcenter.com
Angie Crone, angiewoundcare@gmail.com
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Placental-Based Skin Substitutes and Standard of Care Versus SOC Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
Read the detailed description
The CAMPSTIM trial is a prospective, multicenter, randomized, controlled clinical trial to evaluate four separate CAMPs (Cellular, Acellular, Matrix-like Products), Revita®, Relese®, Cogenex®, and Enverse®. The study utilizes a unique modified platform trial to evaluate multiple cellular and/or tissue-based products (CTPs) in a single trial.
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer Foot, Diabetic Foot, Foot Ulcer
- Being tested
- Standard of Care, Revita, Relese, Cogenex, Enverse
- Keywords
- Cellular, Acellular, Matrix-like Product (CAMP), Cellular and/or Tissue Product (CTP), Dehydrated Complete Human Placental Membrane (dCHPM)
- Medical subject headings
- Diabetic Foot, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
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 12 weeks, whichever occurs first.
RevitaOther
Participants will receive weekly applications of Revita and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
ReleseOther
Participants will receive weekly applications of Relese and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
CogenexOther
Participants will receive weekly applications of Cogenex and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
EnverseOther
Participants will receive weekly applications of Enverse and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading. Receives: Other: Standard of Care |
| Revita | Experimental | Revita is an opaque, lyophilized dehydrated complete human placental membrane (dCHPM) allograft. Receives: Other: Revita |
| Relese | Experimental | Relese is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft. Receives: Other: Relese |
| Cogenex | Experimental | Cognenex is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft. Receives: Other: Cogenex |
| Enverse | Experimental | Enverse is a translucent dehydrated complete human placental membrane (dCHPM) allograft. Receives: Other: Enverse |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of target ulcers achieving complete wound closure
Determine the percent of target ulcers achieving complete wound closure at 12 weeks. In addition, a qualified third-party clinician will independently confirm wound closure.
Measured: 1-12 weeks
Secondary outcomes (6)
Time to closure for the target ulcer
Time to closure will be determined for each treatment group and compared to SOC.
Measured: 1-12 weeks
Percent area reduction
Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to Treatment Visit (TV)-13.
Measured: 1-12 weeks
Adverse events
Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).
Measured: 1-14 weeks
Change in pain in target ulcer
Change in target ulcer pain assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10 where higher score indicates more severe pain and pain-related interference with life and activities) at TV-1, TV-4, TV-7, TV-10, and TV-13.
Measured: 1-14 weeks
Determine improvement in Quality of Life - wQOL
Quality of Life assessed using the Wound Quality of Life (wQOL) checklist at TV-1, TV- 4, TV-7, TV- 10, and TV-13.
Measured: 12 weeks
Determine improvement in Quality of Life - FWS
Quality of Life assessed using the Forgotten Wound Score (FWS) at TV-1, TV- 4, TV-7, TV- 10, and TV-13.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start16 Jul 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 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 Ulcer (DFU)Studies 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
- CAMPSTIM employs a novel modified platform clinical trial design. CAMPSTIM will evaluate several CAMPs, specifically (4) placental-based CAMPs and Standard of Care (SOC) versus SOC alone in the treatment of nonhealing diabetic foot ulcers. The initial plan is to evaluate the four CAMPs identified in this protocol; however, the platform design allows for the inclusion of additional products which will be added following an interval analysis.
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StimLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449638
- Sponsor's protocol ID
- HPM2401.001-M (07/24)
- Acronym
- CAMPSTIM
- Status last verified
- Feb 2026
- First submitted
- 28 May 2024
- Last updated
- 2 Mar 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Placental-Based Skin Substitutes and Standard of Care Versus SOC Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06449638
- Acronym / sponsor ID
- CAMPSTIM / HPM2401.001-M (07/24)
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer Foot, Diabetic Foot, Foot Ulcer
- Keywords
- Cellular, Acellular, Matrix-like Product (CAMP), Cellular and/or Tissue Product (CTP), Dehydrated Complete Human Placental Membrane (dCHPM)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- StimLabsIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jun 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.
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
Detailed description
The CAMPSTIM trial is a prospective, multicenter, randomized, controlled clinical trial to evaluate four separate CAMPs (Cellular, Acellular, Matrix-like Products), Revita®, Relese®, Cogenex®, and Enverse®. The study utilizes a unique modified platform trial to evaluate multiple cellular and/or tissue-based products (CTPs) in a single trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- CAMPSTIM employs a novel modified platform clinical trial design. CAMPSTIM will evaluate several CAMPs, specifically (4) placental-based CAMPs and Standard of Care (SOC) versus SOC alone in the treatment of nonhealing diabetic foot ulcers. The initial plan is to evaluate the four CAMPs identified in this protocol; however, the platform design allows for the inclusion of additional products which will be added following an interval analysis.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareStandard of care will be cleaning, debridement, ulcer moisture balance, and offloading. |
| Revita | Experimental | Other: RevitaRevita is an opaque, lyophilized dehydrated complete human placental membrane (dCHPM) allograft. |
| Relese | Experimental | Other: ReleseRelese is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft. |
| Cogenex | Experimental | Other: CogenexCognenex is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft. |
| Enverse | Experimental | Other: EnverseEnverse is a translucent dehydrated complete human placental membrane (dCHPM) allograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At least 18 years of age or older.
- Diagnosis of type 1 or 2 Diabetes mellitus.
- At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
- 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.
- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
Key exclusion criteria (20 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 |
|---|---|---|
| Standard of CareBeginning 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 12 weeks, whichever occurs first. | Other | Standard of Care |
| RevitaParticipants will receive weekly applications of Revita and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Revita |
| ReleseParticipants will receive weekly applications of Relese and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Relese |
| CogenexParticipants will receive weekly applications of Cogenex and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Cogenex |
| EnverseParticipants will receive weekly applications of Enverse and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Enverse |
Primary outcome
The percentage of target ulcers achieving complete wound closure
Time frame: 1-12 weeks
Determine the percent of target ulcers achieving complete wound closure at 12 weeks. In addition, a qualified third-party clinician will independently confirm wound closure.
6 secondary outcomes
Time to closure for the target ulcer
Time frame: 1-12 weeks
Percent area reduction
Time frame: 1-12 weeks
Adverse events
Time frame: 1-14 weeks
Change in pain in target ulcer
Time frame: 1-14 weeks
Determine improvement in Quality of Life - wQOL
Time frame: 12 weeks
Determine improvement in Quality of Life - FWS
Time frame: 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 2 Mar 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revita, Relese and Cogenex in people with Diabetic Foot Ulcer (DFU) and Ulcer Foot, run by StimLabs at 5 sites 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 20 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Kristy Breisinger (888-960-1343 ext. 1010, kbreisinger@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of target ulcers achieving complete wound 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 2 Mar 2026.