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Topical Oxygen Therapy for Diabetic Wounds

NCT02313428 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-04-25

Study results available
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Summary

This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial. Eleven subjects were enrolled at The Ohio State University; we intend to enroll 29 more subjects at Indiana University. Due to the small sample size this study will primarily be a feasibility study that will attempt to measure and evaluate differences in the relative theoretical costs of the intervention of topical oxygen therapy on this population and subsequently compare outcomes in areas such as overall health improvements and cost effectiveness.

Conditions

  • Diabetic Foot Ulcers
  • Wound

Interventions

DEVICE

Topical Oxygen Chamber for Extremities

Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Chandan K. Sen, PhD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-08-05
Completion
2021-08-05
FDA Device
Yes

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 NCT02313428 on ClinicalTrials.gov