Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life

December 30, 2014 updated by: Chen-Yu Chen
This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE - This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.

RESEARCH DESIGN AND METHODS - This study was a randomized, single-center clinical trial. The effects of HBOT on patients in the experimental group were compared with the control group received only routine care. HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions). Data were collected at 4 segments: pre-treatment (before first administration of HBOT; T1), during treatment (at the tenth administration of HBOT; T2), post-treatment (at the twentieth administration of HBOT; T3), and treatment follow-up (two weeks after the last therapy ended; T4).

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 20 years of age
  • a history of diabetes and a diagnosis of diabetic foot
  • a wound classification of Grade 3 or below
  • clear conscious and willing to participate in this study
  • a signed consent form

Exclusion Criteria:

  • less than 20 years of age, unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hyperbaric oxygen therapy
The experimental group received treatments in a hyperbaric chamber for 120-min per session, once per day, and five days per week for four consecutive weeks (20 treatment sessions).
Device: Hyperbaric oxygen therapy
HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions).
Other Names:
  • HBOT
No Intervention: Control
The control group received only routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound healing
Time Frame: 4 weeks
The Wagner Ulcer Grade Classification System for wound physiological index
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammation index
Time Frame: 4 weeks
Erythrocyte sedimentation rate, ESR; C-reactive protein, CRP
4 weeks
amputation rate
Time Frame: 4 weeks
Number of patients undergo surgical removal of a limb
4 weeks
survival rate of tissue in the affected limb
Time Frame: 4 weeks
blood flow perfusion scan
4 weeks
bacteriological wound cultures
Time Frame: 4 weeks
collect and culture bacteria from the wound to see whether a wound is infected, to identify the bacteria causing the infection
4 weeks
glycemic control
Time Frame: 4 weeks
Glycated Hemoglobin, HbA1c Hemoglobin, HbA1c
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen-Yu Chen

Collaborators

I-Shou University

Investigators

  • Principal Investigator: Chen-Yu Chen, Master, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 25, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-0876B, 101-0507C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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