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RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs

NCT01608776 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2014-10-08

No results posted yet for this study

Summary

To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

MIST Therapy

The MIST Therapy System is used as a non-contact method of delivering ultrasound to treat chronic wounds.

OTHER

SOC - Standard of Care

Standard of Care includes wound cleansing and debridement as needed, moist wound healing dressings, and offloading

Sponsors & Collaborators

  • Celleration, Inc.

    lead INDUSTRY

Principal Investigators

  • Vickie Driver, DPM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • United States

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 NCT01608776 on ClinicalTrials.gov