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50 Participants Needed

Human Placental Membrane Products for Foot and Leg Ulcers

(BIORESCUE Trial)

BS
TS
Overseen ByThomas Serena, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: BioLab Holdings
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I agree to follow the study's required offloading method.
The potential subject must be willing and able to participate in the informed consent process.
The potential subject must agree to attend the weekly study visits required by the protocol.
See 4 more

Exclusion Criteria

My wound is infected or the skin around it is.
The potential subject did not participate in the BIOCAMP trial.
The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of TV-1.
See 17 more

What Are the Treatments Tested in This Trial?

Interventions

  • Human Placental Membrane Products

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Group I: Tri-Membrane Wrap™ VLUExperimental Treatment1 Intervention
Group II: Tri-Membrane Wrap™ DFUExperimental Treatment1 Intervention
Group III: Membrane Wrap™ VLUExperimental Treatment1 Intervention
Group IV: Membrane Wrap™ DFUExperimental Treatment1 Intervention
Group V: Membrane Wrap-Lite™ VLUExperimental Treatment1 Intervention
Group VI: Membrane Wrap-Lite™ DFUExperimental Treatment1 Intervention
Group VII: Membrane Wrap-Hydro™ VLUExperimental Treatment1 Intervention
Group VIII: Membrane Wrap-Hydro™ DFUExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioLab Holdings

Lead Sponsor

Trials
1
Recruited
380+

Serena Group

Collaborator

Trials
6
Recruited
790+

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