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Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers

NCT02209662 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2014-08-06

No results posted yet for this study

Summary

Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be randomized into one of two groups, the Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce growth factors that can help in wound healing.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

APIC-PRP

APIC-PRP

OTHER

Placebo, Saline plus standard of care

Placebo, Saline plus standard of care

Sponsors & Collaborators

  • Cytonics Corporation

    lead INDUSTRY

Principal Investigators

  • Gaetano J Scuderi, MD · Cytonics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-10-31
Completion
2015-12-31

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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 NCT02209662 on ClinicalTrials.gov