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Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care

NCT04332003 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-02-15

No results posted yet for this study

Summary

A double blind, randomized controlled clinical trial comparing wound closure rates of diabetic foot ulcers (DFUs) in subjects receiving active RIC treatment plus standard of care compared to those receiving sham treatment plus standard of care.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Remote Ischemic Conditioning (RIC) Treatment

RIC treatment will be delivered by an automated device that delivers the RIC treatment (manufactured by LifeCuff Technologies).

Sponsors & Collaborators

  • LifeCuff Technologies Inc.

    collaborator INDUSTRY

  • SerenaGroup, Inc.

    lead NETWORK

Principal Investigators

  • Thomas E Serena, MD,FACS · SerenaGroup, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-02-06
Completion
2021-02-06
FDA Device
Yes

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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 NCT04332003 on ClinicalTrials.gov