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

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ClinicalTrials.gov Identifier: NCT02328508
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Collaborator:
I-Shou University
Information provided by (Responsible Party):
Chen-Yu Chen, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetes Device: Hyperbaric oxygen therapy Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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 Name: HBOT

No Intervention: Control
The control group received only routine care.



Primary Outcome Measures :
  1. wound healing [ Time Frame: 4 weeks ]
    The Wagner Ulcer Grade Classification System for wound physiological index


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328508


Sponsors and Collaborators
Chen-Yu Chen
I-Shou University
Investigators
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Principal Investigator: Chen-Yu Chen, Master Chang Gung Memorial Hospital
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Responsible Party: Chen-Yu Chen, Registered Nurse, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02328508    
Other Study ID Numbers: 100-0876B, 101-0507C
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by Chen-Yu Chen, Chang Gung Memorial Hospital:
hyperbaric oxygen therapy
diabetic foot ulcer
wound healing
inflammation
glycemic control
amputation
bacterial infection
quality of life
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases