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

Chen-Yu Chen

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetic Foot Ulcer

Treatments: Device: Hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02328508

100-0876B, 101-0507C

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

hyperbaric oxygen therapy

Experimental group

Description:

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).

Treatment:

Device: Hyperbaric oxygen therapy

Control

No Intervention group

Description:

The control group received only routine care.