Diabetic Foot Ulcer (DFU)NCT07116174
A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs
A study testing Xcell Amnio Matrix in people with Diabetic Foot Ulcer (DFU), run by New Horizon Medical Solutions at 3 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in male and female over the age of 18 years old. 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?
- Xcell Amnio Matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Aug 2025to 15 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
- Subject is 18 years of age or older.
- Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or oral/injectable medications to control blood glucose levels
- Glycosylated hemoglobin (HbA1c) level is <12%
- Note: Prior documented HbA1c within 12 weeks of Screening is acceptable.
- Duration of ulcer is ≥ 4 weeks but ≤ 1 year, unresponsive to SOC
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- Ulcer area is ≥ 1.5cm2 and ≤ 20cm2 and with a clean, granulating base with minimal adherent slough at the Baseline Visit
- Ulcer location is at or below the ankle (malleolus)
- Subject is amenable to use of off-loading, as needed for plantar ulcer
- Ulcer extends through the full thickness of the skin but not down to muscle, tendon, or bone
- Subject is at least 12 weeks post lower extremity revascularization procedure, if one has been performed.
- Subject is in general good health, with no clinically significant medical conditions or abnormalities that, in the opinion of the Investigator, would interfere with study participation, the assessment of study endpoints, or pose additional risk to the subject.
- Adequate circulation to the affected lower extremities as demonstrated by one of the following within 12 weeks of screening:
- Dorsum transcutaneous oxygen measurement (TCOM) ≥ 30 mmHg,
- Skin perfusion pressure (SPP) measurement ≥ 30 mmHg,
- Ankle-Brachial Index (ABI) ≥0.7 and ≤1.2, OR
- Toe-Brachial Index (TBI) ≥ 0.6
- Subject is willing to use an acceptable method of contraception throughout the duration of the trial, if of childbearing potential.
- Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, patch, injectable, depot or vaginal) in conjunction with a barrier method (e.g., diaphragm, cervical cap, condom, spermicide or sponge), or female subject/partner's use of an implantable device (implantable rod or intrauterine device).
- Female subject/partners of non-childbearing potential are defined as surgically sterile (e.g., bilateral tubal ligation, hysterectomy) or two years postmenopausal at time of screening.
- All male subjects (excluding men who have been sterilized) with female partners of child-bearing potential must agree to consistently and correctly use a condom for the duration of the study. In addition, subjects may not donate sperm for the same time period.
- Subject is able to read, understand and sign the informed consent form (ICF).
- Subject is available and willing to complete all study assessments and can comply with standard of care (debridement, dressing changes etc.) as applicable.
Who cannot join
- Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
- Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical antimicrobials.
- Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable).
- Ulceration at the site of amputation.
- Undergoing renal dialysis.
- Known or suspected malignancy in the target ulcer, or a history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer).
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- Documented history of osteomyelitis at the target ulcer location within 6 months of screening.
- History of radiation at the ulcer site.
- New York Heart Association Class III or IV congestive heart failure or uncontrolled cardiac dysrhythmia.
- Diagnosis of autoimmune disease(s) (rheumatoid arthritis, lupus, psoriasis, Sjogren's syndrome) or arthritis requiring corticosteroid treatment.
- Subject has received in the past 4 weeks or is scheduled to receive any of following medication or therapies during the course of the study:
- Immunosuppressants (including chronic systemic corticosteroids or application of topical steroids to the ulcer surface)
- Cytotoxic chemotherapy
- Growth hormone
- Oral or systemic antifungal or antituberculosis treatment
- Use of any investigational drug(s) or therapeutic device(s)
- Target ulcer(s) previously treated with negative pressure, hyperbaric oxygen, or tissue engineered materials (e.g., Apligraf®, EpiFix® or Dermagraft®) or other scaffold materials (e.g., Oasis, Matristem) within 4 weeks prior to screening.
- Target ulcer(s) anticipated to require negative pressure wound therapy or hyperbaric oxygen at any time during the study.
- Healing of target ulcer is observed to be ≥35% at the end of the Run-in Period (between Screening and Baseline Visits)
- Subject is pregnant or breastfeeding.
- Presence of any other condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
- Active Charcot foot (stable chronic Charcot foot is not exclusionary).
- Ulcers on toes 2, 3, 4, and/or 5 only (ulcer on plantar surface of the great toe only is not exclusionary).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kher Lee Ng contact
United States3 sites, 3 recruiting
- Recruiting
Richard C. Galperin
Dallas, Texas, 75208
Richard Galperin, DPM, PA, 214-330-9299 ext. 1003, talus@sbcglobal.net
Richard Galperin, DPM, PA
- Recruiting
Limb Preservation Platform, Inc.
Fresno, California, 93710
Shawn Cazzell, DPM, 559-431-1700, DrCazzell@LPPresearch.com
Shawn Cazzell, DPM
- Recruiting
North Park Podiatry
San Diego, California, 92104
Trent Brookshier, DPM, 619-283-2097, trentbrookshier@gmail.com
Trent Brookshier, DPM
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Clinical Trial Evaluating the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) as Adjunct to Standard of Care (SOC) Therapy Compared to SOC Alone in the Management of Diabetic Foot Ulcers
The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in male and female over the age of 18 years old. The main question it aims to answer is:
What is the proportion of subjects with complete wound closure during the 12 weeks of the treatment phase?
Read more
Participants:
- Will be screened and re-screened after 2 weeks to be assessed whether they meet the eligibility criteria
- Eligible subjects will receive study product application, and for 12 weeks will return to the clinic once every 7 days (±3 days) for treatment visits
- Subjects who complete the treatment will be followed up after 2 weeks
- Conditions
- Diabetic Foot Ulcer (DFU)
- Being tested
- Xcell Amnio Matrix, Standard of Care (SOC)
- Keywords
- DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xcell Amnio MatrixBiological
A lyophilized amniotic membrane allograft
Standard of Care (SOC)Drug
The SOC will be based on investigator's choice
| Study group | Role | What they receive |
|---|---|---|
| Xcell Amnio MatrixTM (XAM) + Standard of Care (SOC) | Experimental | Not described Receives: Biological: Xcell Amnio Matrix |
| Standard of Care (SOC) | Active comparator | Not described Receives: Drug: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase
Complete wound closure is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
Measured: Baseline to12 weeks
Secondary outcomes (3)
Wound Area Change (%) during the 12 weeks of the Treatment Phase
Wound area change is defined as the percentage of wound area change as measured by SnapshotNIR wound imaging device.
Measured: Baseline to 12 weeks
Time to complete wound closure during the 12 weeks of the Treatment Phase
The time of complete closure will be the visit when 100% re-epithelialization without drainage or dressing requirements was first achieved.
Measured: Baseline to 12 weeks
Change in pain in the target ulcer assessed using the Numerical Pain Rating Scale (NPRS) during the 12 weeks of the Treatment Phase.
Minimum value: 0 Maximum value: 100 Higher scores indicate a better outcome (greater satisfaction or improved quality of life related to wound care).
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Aug 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 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
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Horizon Medical Solutions
- Sponsor type
- Research network
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116174
- Sponsor's protocol ID
- XAM-001
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Clinical Trial Evaluating the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) as Adjunct to Standard of Care (SOC) Therapy Compared to SOC Alone in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07116174
- Acronym / sponsor ID
- XAM-001
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- DFU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- New Horizon Medical SolutionsResearch network
- Collaborators
- Amarex Clinical Research
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 11 Aug 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 evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in male and female over the age of 18 years old. The main question it aims to answer is:
What is the proportion of subjects with complete wound closure during the 12 weeks of the treatment phase?
Participants:
- Will be screened and re-screened after 2 weeks to be assessed whether they meet the eligibility criteria
- Eligible subjects will receive study product application, and for 12 weeks will return to the clinic once every 7 days (±3 days) for treatment visits
- Subjects who complete the treatment will be followed up after 2 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xcell Amnio MatrixTM (XAM) + Standard of Care (SOC) | Experimental | Biological: Xcell Amnio Matrix |
| Standard of Care (SOC) | Active comparator | Drug: Standard of Care (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
- Subject is 18 years of age or older.
- Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or oral/injectable medications to control blood glucose levels
- Glycosylated hemoglobin (HbA1c) level is <12%
- Note: Prior documented HbA1c within 12 weeks of Screening is acceptable.
Key exclusion criteria (23 listed)
- Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
- Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical antimicrobials.
- Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable).
- Ulceration at the site of amputation.
- Undergoing renal dialysis.
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 |
|---|---|---|
| Xcell Amnio MatrixA lyophilized amniotic membrane allograft | Biological | Xcell Amnio MatrixTM (XAM) + Standard of Care (SOC) |
| Standard of Care (SOC)The SOC will be based on investigator's choice | Drug | Standard of Care (SOC) |
Primary outcome
Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase
Time frame: Baseline to12 weeks
Complete wound closure is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
3 secondary outcomes
Wound Area Change (%) during the 12 weeks of the Treatment Phase
Time frame: Baseline to 12 weeks
Time to complete wound closure during the 12 weeks of the Treatment Phase
Time frame: Baseline to 12 weeks
Change in pain in the target ulcer assessed using the Numerical Pain Rating Scale (NPRS) during the 12 weeks of the Treatment Phase.
Time frame: Baseline to 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 31 Mar 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.
Kher Lee Ng contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xcell Amnio Matrix in people with Diabetic Foot Ulcer (DFU), run by New Horizon Medical Solutions at 3 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 23 inclusion and 23 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 31 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 3 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 Dawn Shepherd (817-233-1295, dawn.shepherd@nhmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase (time frame: Baseline to12 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 31 Mar 2026.