Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers

February 6, 2025 updated by: Tides Medical

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93710
        • Recruiting
        • Limb Preservation Platform Inc
        • Contact:
      • Los Angeles, California, United States, 90033
      • Los Angeles, California, United States, 90010
      • Vista, California, United States, 92081
        • Recruiting
        • ILD Research Center
        • Contact:
    • Florida
      • Miami, Florida, United States, 33126
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Recruiting
        • Foot and Ankle Specialists of the Mid-Atlantic
        • Contact:
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Recruiting
        • Lower Extremity Institute of Research and Therapy
        • Contact:
          • Sara Chaszeyka
          • Phone Number: (330) 629-8800 - (330) 385-24
          • Email: Sara@leirt.com
      • Circleville, Ohio, United States, 43113
    • Virginia
      • Salem, Virginia, United States, 24153
        • Recruiting
        • Foot and Ankle Specialists of the Mid-Atlantic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Potential subjects are required to meet all of the following criteria for enrollment into the study.

  1. At least 18 years old, inclusive.
  2. Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.
  3. 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.
  4. 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.
  5. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
  6. 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.
  7. The target ulcer has been offloaded for at least 14 days, prior to TV1.
  8. 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.
  9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
  10. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.

Exclusion Criteria:

Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.

  1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
  2. 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
  3. Index ulcer is infected
  4. 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
  5. Subjects on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1
  6. History of radiation at the ulcer site (regardless of time since last radiation treatment)
  7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies
  8. Subjects with a previous diagnosis of HIV or Hepatitis C
  9. 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
  10. 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)
  11. Subject is pregnant or breast-feeding
  12. Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 within last 90 days
  13. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
  14. Presence of acute Charcot Neuroarthropathy to the affected limb
  15. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "Amnion/Chorion/Amnion" common/general allograft configuration
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.
Other: Allograft
Placental-based Allografts
No Intervention: Standard of Care
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.
Other: "Amnion/Chorion" common/general allograft configuration
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.
Other: Allograft
Placental-based Allografts
Other: "Amnion/Amnion" common/general allograft configuration
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.
Other: Allograft
Placental-based Allografts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time to DFU wound closure
Time Frame: 12 Weeks
Length of time to complete wound closure of the indexed DFU
12 Weeks
Percentage of Wound Area Reduction over time of study
Time Frame: 12 Weeks
Percentage area reduction by surface area for each indexed wound during the clinical investigation
12 Weeks
Change in perceived patient wound pain levels over time.
Time Frame: 12 weeks
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').
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of Treatment to Closure Diabetic Foot Ulcer Wound in Study
Time Frame: 12 Weeks
Following costs to treat and closure diabetic foot ulcers in investigational study arms
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tides Medical

Collaborators

Professional Education and Research Institute

Investigators

  • Study Chair: David G Armstrong, DPM, MD, PhD, Keck School of Medicine of USC
  • Study Director: Frank Burrows, MBA, EMT, BCMAS, CWCA, Tides Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2024

Primary Completion (Estimated)

November 18, 2026

Study Completion (Estimated)

November 18, 2026

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TID-ART-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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