Diabetic Foot UlcerNCT06437028
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
A study testing Dual-layer perinatal tissue allograft and Three-layer fenestrated perinatal tissue allograft in people with Diabetic Foot Ulcer, run by Samaritan Biologics at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Dual-layer perinatal tissue allograft and Three-layer fenestrated perinatal tissue allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2025to Mar 2027
- 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
- Potential subjects are required to meet all the following criteria for enrollment in the study.
- Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
- 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.
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- 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. The ulcer may not include exposed tendon or bone.
- 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;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic.
- If the 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
- Potential subjects meeting any of the following criteria will be excluded from enrollment in the study.
- A subject known to have a life expectancy of < 6 months is excluded.
- The subject is excluded if the target ulcer is not secondary to diabetes.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
- If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
- A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
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- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
- The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
- A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
- The subject is excluded if 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). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
- The subject is excluded if 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/randomization visit, during which time the subject received SOC.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
- Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
- A potential subject with end stage renal disease requiring dialysis is excluded.
- Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
- A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
- A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.
- A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).
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
Monroe Biomedical Research
Monroe, North Carolina, 28112
Krista Gross, 704-283-7369, krista.gross@monroeresearch.com
Awawu Igbinadolor, MD
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating the Efficacy of Multiple Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
The main question that this study aims to answer is:
Read more
Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment.
One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
Read the detailed description
Patients with diabetes often develop ulcers on their lower extremities. While some ulcers can be managed using standard of care wound management techniques including debridement, moist dressings, infection control and off-loading, many develop into chronic, non-healing wounds. Chronic non-healing wounds can lead to higher risk of infection, amputation and decreased quality of life.
Advanced wound therapies aim to promote rapid and complete healing of chronic wounds. An example of an advanced wound therapy are perinatal tissue allografts. These include human amniotic / chorionic membranes, which have been confirmed by the United States Food \& Drug Administration's Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the Public Health Service Act as defined in Title 21 of the Code of Federal Regulations - Part 1271 for the management of diabetic foot ulcers.
The focus of this clinical trial is to determine the clinical utility of treating diabetic foot ulcers with weekly applications of perinatal tissue allografts in addition to standard of care wound management techniques compared to applying standard of care wound management only.
It is hypothesized that the addition of perinatal tissue allografts to standard of care treatment will result in a higher percentage of ulcers achieving complete closure (i.e. healing) compared to ulcer being treated with standard of care alone after 12 weeks of treatment.
To test this hypothesis the study will consist of patients who will undergo a 2-week screening phase and a 12-week treatment phase. Briefly, during the 2-week screening phase, patients meeting inclusion criteria will have an identified index wound managed with standard of care. Index wounds that are not reduced by more than 20% in the screening phase will be randomized into the treatment groups. During the 12-week treatment phase, index wounds will be treated weekly with either allograft and standard of care or standard of care alone.
Evaluation of data (outcome measures) associated with the trial will include intent to treat and per protocol analyses which will be performed by at least one blinded statistician and investigator.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Keywords
- Diabetes, Diabetic Foot, Allograft, Amnion, Chorion, Wound healing, Advanced wound care, Comparative effectiveness, Lower extremity ulcer, Time to heal, Treatment, Diabetes complication, Skin ulcer, Neuropathy, Peripheral artery disease, Ischemia, Wagner Grade
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Leg Ulcer, Diabetes Complications, Skin Ulcer, Peripheral Arterial Disease, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-layer perinatal tissue allograftOther
The dual-layer perinatal tissue allograft is an amnion - amnion allograft
Three-layer fenestrated perinatal tissue allograftOther
The three-layer fenestrated perinatal tissue allograft is an amnion - chorion - amnion allograft
Standard of careOther
Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.
| Study group | Role | What they receive |
|---|---|---|
| Dual-layer perinatal tissue allograft | Experimental | Patients will receive weekly applications of a dual-layer perinatal tissue allograft in addition to standard of care wound management. Receives: Other: Dual-layer perinatal tissue allograft; Other: Standard of care |
| Three-layer fenestrated perinatal tissue allograft | Experimental | Patients will receive weekly applications of a three-layer fenestrated perinatal tissue allograft in addition to standard of care wound management. Receives: Other: Three-layer fenestrated perinatal tissue allograft; Other: Standard of care |
| Standard of care (SOC) wound management | Active comparator | Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading. Receives: Other: 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
The percentage of wounds completely healed. Complete healing will be defined as 100% epithelialization without drainage and need for dressing or wound size ≤ 0.1cm^2 as determined by the site investigator and validated by a blinded review board.
Measured: 12-weeks following study screening phase
Secondary outcomes (5)
Time to wound closure
Time to wound closure over 12 weeks will be determined via a Kaplan-Meier analysis
Measured: 12-weeks following study screening phase
Percent reduction in wound area
Percent reduction of wound area [(Ai-Axw]) / Ai] x100, where Ai is the area of the index wound at randomization, Axw is the wound area at weekly intervals.
Measured: 12-weeks following study screening phase
Reduction in Adverse Events
A symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries will be regarded as adverse events. Abnormal results of laboratory or diagnostic procedures are considered to be adverse events if the abnormality:
- Results in study withdrawal.
- Is associated with a serious adverse event.
- Is associated with clinical signs or symptoms.
- Leads to additional treatment or to further diagnostic tests.
- Is considered by the Investigator to be of clinical significance
Measured: 12-weeks following study screening phase
Forgotten Wound Score Measure
Forgotten Wound Score Measure
Measured: 12-weeks following study screening phase
Wound Quality of life questionnaire
Wound-QoL questionnaire on quality of life with chronic wounds
Measured: 12-weeks following study screening phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start9 May 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be modified platform design in which two treatment groups will be compared to one control group initially. However, this study design will enable the inclusion of additional study groups over time while concomitantly increasing the control group size to maintain adequate power.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samaritan Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Responsible party
- Sponsor
- Investigators
- Thomas E Serena, MD, Principal investigator, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437028
- Sponsor's protocol ID
- SB-24-01
- Status last verified
- Aug 2026
- First submitted
- 24 May 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 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 the Efficacy of Multiple Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers.
- ClinicalTrials.gov ID
- NCT06437028
- Acronym / sponsor ID
- SB-24-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, Diabetic Foot, Allograft, Amnion, Chorion, Wound healing, Advanced wound care, Comparative effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Samaritan BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Study start
- 9 May 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 31 May 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 goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
The main question that this study aims to answer is:
Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment.
One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
Detailed description
Patients with diabetes often develop ulcers on their lower extremities. While some ulcers can be managed using standard of care wound management techniques including debridement, moist dressings, infection control and off-loading, many develop into chronic, non-healing wounds. Chronic non-healing wounds can lead to higher risk of infection, amputation and decreased quality of life.
Advanced wound therapies aim to promote rapid and complete healing of chronic wounds. An example of an advanced wound therapy are perinatal tissue allografts. These include human amniotic / chorionic membranes, which have been confirmed by the United States Food \& Drug Administration's Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the Public Health Service Act as defined in Title 21 of the Code of Federal Regulations - Part 1271 for the management of diabetic foot ulcers.
The focus of this clinical trial is to determine the clinical utility of treating diabetic foot ulcers with weekly applications of perinatal tissue allografts in addition to standard of care wound management techniques compared to applying standard of care wound management only.
It is hypothesized that the addition of perinatal tissue allografts to standard of care treatment will result in a higher percentage of ulcers achieving complete closure (i.e. healing) compared to ulcer being treated with standard of care alone after 12 weeks of treatment.
To test this hypothesis the study will consist of patients who will undergo a 2-week screening phase and a 12-week treatment phase. Briefly, during the 2-week screening phase, patients meeting inclusion criteria will have an identified index wound managed with standard of care. Index wounds that are not reduced by more than 20% in the screening phase will be randomized into the treatment groups. During the 12-week treatment phase, index wounds will be treated weekly with either allograft and standard of care or standard of care alone.
Evaluation of data (outcome measures) associated with the trial will include intent to treat and per protocol analyses which will be performed by at least one blinded statistician and investigator.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study will be modified platform design in which two treatment groups will be compared to one control group initially. However, this study design will enable the inclusion of additional study groups over time while concomitantly increasing the control group size to maintain adequate power.
| Arm | Type | Receives |
|---|---|---|
| Dual-layer perinatal tissue allograft | Experimental | Other: Dual-layer perinatal tissue allograft, Other: Standard of carePatients will receive weekly applications of a dual-layer perinatal tissue allograft in addition to standard of care wound management. |
| Three-layer fenestrated perinatal tissue allograft | Experimental | Other: Three-layer fenestrated perinatal tissue allograft, Other: Standard of carePatients will receive weekly applications of a three-layer fenestrated perinatal tissue allograft in addition to standard of care wound management. |
| Standard of care (SOC) wound management | Active comparator | Other: Standard of careStandard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Potential subjects are required to meet all the following criteria for enrollment in the study.
- Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
- 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.
Key exclusion criteria (19 listed)
- Potential subjects meeting any of the following criteria will be excluded from enrollment in the study.
- A subject known to have a life expectancy of < 6 months is excluded.
- The subject is excluded if the target ulcer is not secondary to diabetes.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
- If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
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 |
|---|---|---|
| Dual-layer perinatal tissue allograftThe dual-layer perinatal tissue allograft is an amnion - amnion allograft | Other | Dual-layer perinatal tissue allograft |
| Three-layer fenestrated perinatal tissue allograftThe three-layer fenestrated perinatal tissue allograft is an amnion - chorion - amnion allograft | Other | Three-layer fenestrated perinatal tissue allograft |
| Standard of careStandard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading. | Other | Dual-layer perinatal tissue allograft, Standard of care (SOC) wound management, Three-layer fenestrated perinatal tissue allograft |
Primary outcome
Incidence of Complete Wound Closure
Time frame: 12-weeks following study screening phase
The percentage of wounds completely healed. Complete healing will be defined as 100% epithelialization without drainage and need for dressing or wound size ≤ 0.1cm^2 as determined by the site investigator and validated by a blinded review board.
5 secondary outcomes
Time to wound closure
Time frame: 12-weeks following study screening phase
Percent reduction in wound area
Time frame: 12-weeks following study screening phase
Reduction in Adverse Events
Time frame: 12-weeks following study screening phase
Forgotten Wound Score Measure
Time frame: 12-weeks following study screening phase
Wound Quality of life questionnaire
Time frame: 12-weeks following study screening phase
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 Sep 2026.
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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.
Thomas E Serena, MD principal investigator
SerenaGroup, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-layer perinatal tissue allograft and Three-layer fenestrated perinatal tissue allograft in people with Diabetic Foot Ulcer, run by Samaritan 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 17 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 2 Sep 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.
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 Jeremy J Mercuri, PhD (484-883-2033, jmercuri@samaritanbiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Complete Wound Closure (time frame: 12-weeks following study screening phase). 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 Sep 2026.