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

Phase 1

Completed

• Conditions: Diabetes; Diabetic Foot Ulcer
• Interventions: Device: Hyperbaric oxygen therapy

• Registration Number: NCT02328508
• Lead Sponsor: Chen-Yu Chen

Brief Summary

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.

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 Timeline

• Study Start: 2011-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-12
• Study First Submitted: 2014-12-25
• Study First Submitted QC: 2014-12-30
• Last Update Submitted: 2014-12-30
• Study First Posted: 2014-12-31
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyperbaric oxygen therapy	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).

Primary Outcome Measures

Name	Time	Method
wound healing	4 weeks	The Wagner Ulcer Grade Classification System for wound physiological index

Secondary Outcome Measures

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