Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
Recruiting
Phase 4
Interventional Study
Diabetic Foot Ulcer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Cellution Biologics · Industry
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About This Trial
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Subjects will be eligible to participate in the study if the following conditions exist:
Inclusion Criteria:
1. 18 years of age or older.
2. Diagnosis of type 1 or 2 Diabetes mellitus.
3. Hemoglobin A1c (HbA1c) level is \< 12% (108 mmol/mol).
4. Target ulcer with a surface are…
Contacts