Diabetic Foot Ulcer (DFU)NCT06681428
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
A study testing Allograft in people with Diabetic Foot Ulcer (DFU) and Chronic Foot Ulcers, run by Tides Medical at 9 sites in United States.
Trial summary
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers
- What is being tested?
- Allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Nov 2024to 18 Nov 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
- Potential subjects are required to meet all of the following criteria for enrollment into the study.
- At least 18 years old, inclusive.
- Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.
- The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
- Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
- Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
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- Within 3 months of SV1, adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of > 0.6 is acceptable.
- The target ulcer has been offloaded for at least 14 days, prior to TV1.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
- Subjects must have read and signed the IRB approved ICF before screening procedures are performed.
Who cannot join
- Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
- Index ulcer is infected
- Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study
- Subjects on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1
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- History of radiation at the ulcer site (regardless of time since last radiation treatment)
- Index ulcer has been previously treated or will need to be treated with any prohibited therapies
- Subjects with a previous diagnosis of HIV or Hepatitis C
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment
- Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision)
- Subject is pregnant or breast-feeding
- Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 within last 90 days
- Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
- Presence of acute Charcot Neuroarthropathy to the affected limb
- Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Lower Extremity Institute of Research and Therapy
Boardman, Ohio, 44512
Sara Chaszeyka, (330) 629-8800 - (330) 385-24, Sara@leirt.com
- Recruiting
Brock Liden DPM
Circleville, Ohio, 43113
Rhonda Queen, 740-474-3850, Researchnurse45601@gmail.com
- Recruiting
Limb Preservation Platform Inc
Fresno, California, 93710
Destiny Blackstone, 559-431-1700, destiny@lppresearch.com
- Recruiting
Angel City Research
Los Angeles, California, 90010
Joanna Cuevas, 213-365-0793, joanna@angelcityresearch.com
- Recruiting
Clemente Clinical Research
Los Angeles, California, 90033
Ernestina Uribe, 323-330-2880, Ernestina.uribe@clementeclinical.com
- Recruiting
Clever Medical Research
Miami, Florida, 33126
Margarita Hernandez, 305-648-6381, mhernandez@clevermedresearch.com
- Recruiting
Foot and Ankle Specialists of the Mid-Atlantic
Raleigh, North Carolina, 27609
Allison Denton, 919 213-0261, adenton@us-fas.com
- Recruiting
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, 24153
Kristie Cooper, 540-344-3668, kcooper@us-fas.com
- Recruiting
ILD Research Center
Vista, California, 92081
Eric Martinez, 760-350-5080, eric@ildresearch.com
About this study
Official title: A Multi-Center, Randomized Controlled Clinical Investigation Evaluating an Amnion/Chorion/Amnion Allograft, Amnion/Chorion Allograft, And/or an Amnion/Amnion Allograft Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
- Conditions
- Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers
- Being tested
- Allograft
- Keywords
- Amnion, Chorion, Amnion Amnion Graft, Amnion Chorion Amnion Grafts, Amnion Chorion Graft, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Pathologic Processes, Ulcer, Skin Ulcer, Chronic Ulcer, Chronic Foot Ulcer, Diabetic Angiopathies, Diabetes Type 2, Diabetes Type II, Leg Ulcer, Placental-Based Allografts, Human Placental-Based Skin Grafts
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Pathologic Processes, Ulcer, Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllograftOther
Placental-based Allografts
| Study group | Role | What they receive |
|---|---|---|
| "Amnion/Chorion/Amnion" common/general allograft configuration | Experimental | Topical application of placental allograft on to surface of open chronic diabetic foot ulcer using a tri-layer dehydrated amniotic membrane allograft for the treatment of DFUs. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta, the organ that connects the developing fetus to the mother's uterus. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix which provides a natural scaffold that allows cellular attachment or infiltration and growth factor storage. Receives: Other: Allograft |
| Standard of Care | No intervention | Standard of Care (SOC) for open chronic diabetic foot ulcer using a calcium alginate dressing and will have a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent) applied. Offloading of the DFU (removable offloading boot or total contact casting [TCC] if the subject's foot is too large for a removable offloading boot), appropriate sharp or surgical debridement, and infection management. Graft provides a protective cover and supports the body's wound healing processes. This allograft is supplied sterile and not intended to be removed. |
| "Amnion/Chorion" common/general allograft configuration | Other | Topical application of placental allograft on to surface of open chronic diabetic foot ulcer using a dehydrated human amniotic membrane allograft comprised of a tri-layer membrane (amnion/intermediate layer/chorion) which provides a natural scaffold that allows cellular attachment and infiltration. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix. Graft provides a protective cover and supports the body's wound healing processes. This allograft is supplied sterile and not intended to be removed. Receives: Other: Allograft |
| "Amnion/Amnion" common/general allograft configuration | Other | Topical application of placental allograft on to surface of open chronic diabetic foot ulcer using a dual layer dehydrated human amniotic membrane allograft. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta, the organ that connects the developing fetus to the mother's uterus. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix which provides a natural scaffold that allows cellular attachment or infiltration and growth factor storage. This allograft provides a protective cover and supports the body's wound healing process. This allograft is supplied sterile and not intended to be removed. Receives: Other: Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of DFUs healed at 12 weeks
Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks
Measured: 12 Weeks
Secondary outcomes (3)
Total time to DFU wound closure
Length of time to complete wound closure of the indexed DFU
Measured: 12 Weeks
Percentage of Wound Area Reduction over time of study
Percentage area reduction by surface area for each indexed wound during the clinical investigation
Measured: 12 Weeks
Change in perceived patient wound pain levels over time.
Change in patient pain levels during the clinical investigation at the wound site using the pain assessment by questionnaire. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
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 posted8 Nov 2024
- Study start14 Nov 2024
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Nov 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tides Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Responsible party
- Sponsor
- Investigators
- David G Armstrong, DPM, MD, PhD, Study chair, Keck School of Medicine of USCFrank Burrows, MBA, EMT, BCMAS, CWCA, Study director, Tides Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681428
- Sponsor's protocol ID
- TID-ART-01
- Status last verified
- Feb 2025
- First submitted
- 4 Nov 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized Controlled Clinical Investigation Evaluating an Amnion/Chorion/Amnion Allograft, Amnion/Chorion Allograft, And/or an Amnion/Amnion Allograft Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06681428
- Acronym / sponsor ID
- TID-ART-01
- Conditions
- Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers
- Keywords
- Amnion, Chorion, Amnion Amnion Graft, Amnion Chorion Amnion Grafts, Amnion Chorion Graft, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tides MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 18 Nov 2026 (estimated)
- First posted
- 8 Nov 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 clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| "Amnion/Chorion/Amnion" common/general allograft configuration | Experimental | Other: AllograftTopical application of placental allograft on to surface of open chronic diabetic foot ulcer using a tri-layer dehydrated amniotic membrane allograft for the treatment of DFUs. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta, the organ that connects the developing fetus to the mother's uterus. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix which provides a natural scaffold that allows cellular attachment or infiltration and growth factor storage. |
| Standard of Care | No intervention | –Standard of Care (SOC) for open chronic diabetic foot ulcer using a calcium alginate dressing and will have a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent) applied. Offloading of the DFU (removable offloading boot or total contact casting [TCC] if the subject's foot is too large for a removable offloading boot), appropriate sharp or surgical debridement, and infection management. Graft provides a protective cover and supports the body's wound healing processes. This allograft is supplied sterile and not intended to be removed. |
| "Amnion/Chorion" common/general allograft configuration | Other | Other: AllograftTopical application of placental allograft on to surface of open chronic diabetic foot ulcer using a dehydrated human amniotic membrane allograft comprised of a tri-layer membrane (amnion/intermediate layer/chorion) which provides a natural scaffold that allows cellular attachment and infiltration. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix. Graft provides a protective cover and supports the body's wound healing processes. This allograft is supplied sterile and not intended to be removed. |
| "Amnion/Amnion" common/general allograft configuration | Other | Other: AllograftTopical application of placental allograft on to surface of open chronic diabetic foot ulcer using a dual layer dehydrated human amniotic membrane allograft. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta, the organ that connects the developing fetus to the mother's uterus. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix which provides a natural scaffold that allows cellular attachment or infiltration and growth factor storage. This allograft provides a protective cover and supports the body's wound healing process. This allograft is supplied sterile and not intended to be removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Potential subjects are required to meet all of the following criteria for enrollment into the study.
- At least 18 years old, inclusive.
- Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.
- The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
- Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
Key exclusion criteria (16 listed)
- Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
- Index ulcer is infected
- Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study
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 |
|---|---|---|
| AllograftPlacental-based Allografts | Other | "Amnion/Amnion" common/general allograft configuration, "Amnion/Chorion" common/general allograft configuration, "Amnion/Chorion/Amnion" common/general allograft configuration |
Primary outcome
Percentage of DFUs healed at 12 weeks
Time frame: 12 Weeks
Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks
3 secondary outcomes
Total time to DFU wound closure
Time frame: 12 Weeks
Percentage of Wound Area Reduction over time of study
Time frame: 12 Weeks
Change in perceived patient wound pain levels over time.
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 10 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
David G Armstrong, DPM, MD, PhD study chair
Keck School of Medicine of USC
Frank Burrows, MBA, EMT, BCMAS, CWCA study director
Tides Medical
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allograft in people with Diabetic Foot Ulcer (DFU) and Chronic Foot Ulcers, run by Tides Medical at 9 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 11 inclusion and 16 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Frank Burrows III, MBA, EMT, BCMAS, CWCA (888-494-4441, FBurrows@tidesmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of DFUs healed at 12 weeks (time frame: 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 10 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.