search
Back to results

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

Primary Purpose

Diabetic Foot Ulcer, Diabetes

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
Sponsored by
Chen-Yu Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring hyperbaric oxygen therapy, diabetic foot ulcer, wound healing, inflammation, glycemic control, amputation, bacterial infection, quality of life

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    hyperbaric oxygen therapy

    Control

    Arm 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).

    The control group received only routine care.

    Outcomes

    Primary Outcome Measures

    wound healing
    The Wagner Ulcer Grade Classification System for wound physiological index

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 25, 2014
    Last Updated
    December 30, 2014
    Sponsor
    Chen-Yu Chen
    Collaborators
    I-Shou University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02328508
    Brief Title
    Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
    Official Title
    Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Chen-Yu Chen
    Collaborators
    I-Shou University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot Ulcer, Diabetes
    Keywords
    hyperbaric oxygen therapy, diabetic foot ulcer, wound healing, inflammation, glycemic control, amputation, bacterial infection, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    hyperbaric oxygen therapy
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group received only routine care.
    Intervention Type
    Device
    Intervention Name(s)
    Hyperbaric oxygen therapy
    Other Intervention Name(s)
    HBOT
    Intervention Description
    HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions).
    Primary Outcome Measure Information:
    Title
    wound healing
    Description
    The Wagner Ulcer Grade Classification System for wound physiological index
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    inflammation index
    Description
    Erythrocyte sedimentation rate, ESR; C-reactive protein, CRP
    Time Frame
    4 weeks
    Title
    amputation rate
    Description
    Number of patients undergo surgical removal of a limb
    Time Frame
    4 weeks
    Title
    survival rate of tissue in the affected limb
    Description
    blood flow perfusion scan
    Time Frame
    4 weeks
    Title
    bacteriological wound cultures
    Description
    collect and culture bacteria from the wound to see whether a wound is infected, to identify the bacteria causing the infection
    Time Frame
    4 weeks
    Title
    glycemic control
    Description
    Glycated Hemoglobin, HbA1c Hemoglobin, HbA1c
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chen-Yu Chen, Master
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs