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Evaluation of ABSOLVE in Diabetic Foot Ulcers

NCT03037970 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-01-31

No results posted yet for this study

Summary

ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE is under development for the treatment of chronic and acute wounds. This study investigates the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).

Conditions

  • Diabetic Foot Ulcers

Interventions

DRUG

RhPDGF-BB

One 2x4x.3cm of collagen wound matrix is saturated with 2.0 ml of the rhPDGF-BB solution.

OTHER

Placebo

Collagen Wound Dressing wetted with buffer.

Sponsors & Collaborators

  • Medelis Inc.

    collaborator INDUSTRY

  • Centro Medico Militar

    collaborator UNKNOWN

  • Lynch Biologics LLC

    lead INDUSTRY

Principal Investigators

  • Luis Gonzalez, MD · Centro Medico Militar, Guatemala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2017-08-15
Completion
2017-10-15

Countries

  • Guatemala

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03037970 on ClinicalTrials.gov