A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.
Recruiting
Phase 4
Interventional Study
Diabetic Foot Ulcer
Foot Ulcer Chronic
DFU
Ulcer Foot
Venous Leg Ulcer (VLU)
Venous Leg Ulcer
Venous Ulcer
Leg Ulcers
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
- 50 (estimated)
- Sponsor
- BioLab Holdings · Industry
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About This Trial
The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* The potential subject must be at least 18 years of age or older.
* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
* If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the BIOCAMP study.
* The poten…
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