Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTides Medical
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Allograft
Treatment groups
240 Participants
are divided into 4 treatment groupsSponsors and collaborators
Tides Medical
Lead sponsor
Professional Education and Research Institute
Collaborator
Source ClinicalTrials.gov