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

ConditionsDiabetic Foot Ulcer (DFU)Chronic 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Allograft
Other intervention
Placental-based Allografts

Treatment groups

240 Participants

are divided into 4 treatment groups

Group A: "Amnion/Chorion/Amnion" common/general allograft configurationExperimental treatment 1 intervention

Group B: Standard of CareNo intervention 0 interventions

Group C: "Amnion/Chorion" common/general allograft configurationOther 1 intervention

Group D: "Amnion/Amnion" common/general allograft configurationOther 1 intervention

Trial outcomes

Primary outcomes

Percentage of DFUs healed at 12 weeks

Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks

Time frame

12 Weeks

Secondary outcomes

Total time to DFU wound closure

Length of time to complete wound closure of the indexed DFU

Time frame

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

Time frame

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').

Time frame

12 weeks

Other outcomes

Cost of Treatment to Closure Diabetic Foot Ulcer Wound in Study

Following costs to treat and closure diabetic foot ulcers in investigational study arms

Time frame

12 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tides Medical

Lead sponsor

Professional Education and Research Institute

Collaborator

Source ClinicalTrials.gov

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