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Completed

NCT Number: NCT02328508

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

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.

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Key information

Conditions

Diabetic Foot Ulcer Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Diabetes Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Infections Inflammation Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyperbaric oxygen therapy

Device

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

Primary outcomes

  1. wound healing

    Time frame: 4 weeks

    The Wagner Ulcer Grade Classification System for wound physiological index

Secondary outcomes

  1. inflammation index

    Time frame: 4 weeks

    Erythrocyte sedimentation rate, ESR; C-reactive protein, CRP

  2. amputation rate

    Time frame: 4 weeks

    Number of patients undergo surgical removal of a limb

  3. survival rate of tissue in the affected limb

    Time frame: 4 weeks

    blood flow perfusion scan

  4. 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

  5. glycemic control

    Time frame: 4 weeks

    Glycated Hemoglobin, HbA1c Hemoglobin, HbA1c

Sponsors and collaborators

Lead sponsor

Chen-Yu Chen

Other

Collaborators

  • I-Shou University

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 31, 2014
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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