Diabetic Foot Ulcer (DFU)NCT07290673
Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers
A study testing FoundationDRS Solo in people with Diabetic Foot Ulcer (DFU), run by Samaritan Biologics at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does FoundationDRS Solo, when used in conjunction with standard of care wound management techniques, result in a higher… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- FoundationDRS Solo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Dec 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
- 1. Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus requiring treatment with oral medications and/or insulin replacement therapy.
- 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 prior to randomization at treatment visit 1 (TV1).
- The target ulcer must have been present for a minimum of 4 weeks and is unresponsive (defined by less than 50% wound area reduction) to standard wound care.
- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- 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 either malleoli.
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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:
- ABI between 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic;
- skin perfusion pressure (SPP) ≥ 30 mmHg.
- 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.
- The index ulcer has been offloaded with protocol defined offloading device for at least 14 days prior to randomization (i.e. Screening through TV1/Randomization).
- 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.
- Index ulcer and/or index ulcer limb may have had prior infection(s), but must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1 (Appendix L).
- The index ulcer has a clean base and is free from necrotic debris at time of placement of product / treatment.
- Negative pregnancy test for females of childbearing potential (e.g., not post-menopausal for at least one yar or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.
Who cannot join
- The target ulcer has been present for more than 52 weeks.
- The ulcer includes exposed tendon or bone.
- 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 has cellulitis in the surrounding skin.
- There is evidence of osteomyelitis complicating the target ulcer.
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- The potential subject has an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject has a previous partial amputation on the affected foot that resulted in a deformity impeding proper offloading of the target ulcer.
- A potential subject must be excluded if either of the following conditions are met:
- Condition A (Overall 4-week reduction)
- The surface are of the target ulcer has decreased by more than 50% over the 4 weeks prior to Treatment Visit 1, which includes:
- The historical run-in period, and
- The 2-week Screening Phase.
- OR
- Condition B (Sequential reductions across both phases)
- Both of the following are true:
- During the historical run-in period (the 2-weeks prior to the Screening Visit):
- The target ulcer surface area decreases by more than 25%.
- During the active 2-week Screening Phase (from Screening Visit 1 [SV1] to Treatment Visit 1 [TV1]):
- The target ulcer surface area decreases by an additional 25% or more.
- 12. The surface area of the potential subject's target ulcer has reduced in size by more than 50% in the 4 weeks prior to Treatment Visit 1 (i.e. 2-week historical run-in and 2-week screening phase).
- 13. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- 14. The potential subject has an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.
- 15. The potential subject is pregnant or considering becoming pregnant within the next 6 months.
- 16. The potential subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- 17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
- 18. The potential subject has, in the opinion of the investigator, a medical or psychological condition that may interfere with study assessments.
- 19. The potential subject is treated with hyperbaric oxygen therapy or cellular, acellular and matrix-like products (CAMPS) in the 30 days prior to the initial screening visit .
- 20. The potential subject has a score of less than 17 and is considered malnourished according to the Mini Nutritional Assessment (MNA).
- 21. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
- 22. Subject has ulcers that are completely necrotic or fibrotic tissue. 23. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.
- 24. Known contraindications to or known allergies to any of the Foundation DRS Solo components.
- 25. Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).
- 26. Index ulcer and/or index limb with presence of gangrene or unstable ischemia at the initial screening visit (SV1).
- 27. Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
- 28. Any clinically significant finding, in the judgment of the Principal Investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.
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
Alma Medical and Research Services
Hollywood, Florida, 33021
Yadira Manso, 305-631-5975, drmanso@almamedresearch.com
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Foundation DRS Solo as an Adjunct to 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 FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.
The main question that this study aims to answer is:
Read more
Does FoundationDRS Solo, when used 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 applications of 1) FoundationDRS Solo 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. Examples of an advanced wound therapies include scaffolds that contain and / or mimic the structure and function of the natural extracellular matrix of tissue. Several biomimetic scaffolds have been cleared for the management of a variety of wounds (including DFU's) by the US FDA.
The focus of this clinical trial is to determine the clinical utility of treating diabetic foot ulcers with weekly applications of FoundationDRS Solo 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 FoundationDRS Solo 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 standard of care for 4-weeks prior to entering a 12-week treatment phase. During the 4-week standard of care phase, patients meeting inclusion criteria (including confirmation that ulcer does not reduce in area by more than 50%) will be randomized into the treatment groups. During the 12-week treatment phase, index wounds will be treated weekly with FoundationDRS Solo 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 (DFU)
- Being tested
- FoundationDRS Solo, Standard of Care
- Keywords
- Diabetes, Diabetic Foot, Allograft, Scaffold, 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.
FoundationDRS SoloOther
Also called Foundation DRS
FoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate
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 |
|---|---|---|
| FoundationDRS Solo | Experimental | FoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate Receives: Other: FoundationDRS Solo; Other: Standard of Care |
| Standard of Care | 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 (4)
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
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:
Leads to 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
Wound Quality of life (Wound-QoL) questionnaire
Average scores will range from 0 (lowest score) to 4 (highest score), with a higher score indicating that the wound effected the subject's quality of life more severely.
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 posted18 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a multicenter, prospective, randomized design in which one treatment group will be compared to one control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samaritan Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergent Clinical Consulting, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290673
- Sponsor's protocol ID
- SB-25-1
- Status last verified
- Jan 2026
- First submitted
- 30 Oct 2025
- Last updated
- 9 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Foundation DRS Solo as an Adjunct to Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers.
- ClinicalTrials.gov ID
- NCT07290673
- Acronym / sponsor ID
- SB-25-1
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- Diabetes, Diabetic Foot, Allograft, Scaffold, Wound Healing, Advanced Wound Care, Comparative Effectiveness, Lower Extremity Ulcer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Samaritan BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- Emergent Clinical Consulting, LLC
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Dec 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 clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.
The main question that this study aims to answer is:
Does FoundationDRS Solo, when used 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 applications of 1) FoundationDRS Solo 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. Examples of an advanced wound therapies include scaffolds that contain and / or mimic the structure and function of the natural extracellular matrix of tissue. Several biomimetic scaffolds have been cleared for the management of a variety of wounds (including DFU's) by the US FDA.
The focus of this clinical trial is to determine the clinical utility of treating diabetic foot ulcers with weekly applications of FoundationDRS Solo 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 FoundationDRS Solo 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 standard of care for 4-weeks prior to entering a 12-week treatment phase. During the 4-week standard of care phase, patients meeting inclusion criteria (including confirmation that ulcer does not reduce in area by more than 50%) will be randomized into the treatment groups. During the 12-week treatment phase, index wounds will be treated weekly with FoundationDRS Solo 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
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a multicenter, prospective, randomized design in which one treatment group will be compared to one control group.
| Arm | Type | Receives |
|---|---|---|
| FoundationDRS Solo | Experimental | Other: FoundationDRS Solo, Other: Standard of CareFoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate |
| Standard of Care | 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 (20 listed)
- 1. Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus requiring treatment with oral medications and/or insulin replacement therapy.
- 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 prior to randomization at treatment visit 1 (TV1).
- The target ulcer must have been present for a minimum of 4 weeks and is unresponsive (defined by less than 50% wound area reduction) to standard wound care.
- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
Key exclusion criteria (38 listed)
- The target ulcer has been present for more than 52 weeks.
- The ulcer includes exposed tendon or bone.
- 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 has cellulitis in the surrounding skin.
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 |
|---|---|---|
| FoundationDRS SoloAlso: Foundation DRSFoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate | Other | FoundationDRS Solo |
| 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 | FoundationDRS Solo, Standard of Care |
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.
4 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
Adverse Events
Time frame: 12-weeks following study screening phase
Wound Quality of life (Wound-QoL) 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 9 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoundationDRS Solo in people with Diabetic Foot Ulcer (DFU), 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 20 inclusion and 38 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: opening soon, as of the sponsor's last update on 9 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 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 9 Mar 2026.