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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328508
• Other study ID #: 100-0876B, 101-0507C
• Status: Completed
• Phase: Phase 1
• First received: December 25, 2014
• Last updated: December 30, 2014
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2014
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chen-Yu Chen	I-Shou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing	The Wagner Ulcer Grade Classification System for wound physiological index	4 weeks	No
Secondary	inflammation index	Erythrocyte sedimentation rate, ESR; C-reactive protein, CRP	4 weeks	No
Secondary	amputation rate	Number of patients undergo surgical removal of a limb	4 weeks	No
Secondary	survival rate of tissue in the affected limb	blood flow perfusion scan	4 weeks	No
Secondary	bacteriological wound cultures	collect and culture bacteria from the wound to see whether a wound is infected, to identify the bacteria causing the infection	4 weeks	No
Secondary	glycemic control	Glycated Hemoglobin, HbA1c Hemoglobin, HbA1c	4 weeks	No