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Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675269
Recruitment Status : Withdrawn (Study was moved to another location with involvement of different researchers)
First Posted : September 18, 2018
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
University of Stellenbosch
Information provided by (Responsible Party):
King Hamad University Hospital, Bahrain

Brief Summary:

Diabetic foot ulcers are associated with high risk of amputation. About 50% of patients undergoing non-traumatic lower limb amputations are diabetics5. The 5-year amputation rate is estimated to be 19% with a mean time to amputation 58 months since the onset of an diabetic foot ulcer6.Because infection and tissue hypoxia are the major contributing factors for non-healing diabetic foot ulcers, hyperbaric oxygen therapy (HBO) carries a potential benefit for treating these problematic wounds that do not respond to standard therapy.

The role of oxygen in the wound healing cascade and subsequent combatting action against bacterial invasion, especially anaerobes, is well documented.14 Delayed or arrested healing and the development of infection is a direct result from decreased perfusion and poor oxygenation of tissue.15 The presence of wound hypoxia is an major etiological pathway in the development of chronic non-healing diabetic foot ulcers


Condition or disease Intervention/treatment Phase
Ulcer Foot Diabetic Foot Ulcer Other: HBOT Behavioral: Standard wound care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer: A Prospective Double-Blind, Randomized Control Clinical Trail
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
HBOT
Other: HBOT
Standard practice

Behavioral: Standard wound care
Standard wound care

Active Comparator: Control
Standard wound care
Behavioral: Standard wound care
Standard wound care




Primary Outcome Measures :
  1. Change in wound size [ Time Frame: 4 years ]
    The change of wound size at 4 weeks (granulation formation) as measured by the Silhouette three dimensional photography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Any gender aged > 18 years.
  2. Confirmed type 1 or type 2 Diabetes Mellitus patient, currently on anti-diabetic medication
  3. Participant is to have at least one wound, which meets ALL of the following criteria: a. The ulcer to be present on the lower extremity below the ankle joint to make this study comparable to others done on diabetic patients b. Documented proof of chronicity (present for more than 3 months, despite conventional wound care).

    c. Wagner classification Grade 3 or higher as recommended by the Undersea and Hyperbaric Medical Society.

  4. Meeting the selection for HBO criteria as determined by transcutaneous oxygen measurements.
  5. Willing and able to provide an informed consent for the study and related procedures.

Exclusion Criteria:

  1. Lower extremity or foot ulcers of non-diabetic peripheral vascular disease, venous, lymphedematous or neoplastic etiology.
  2. Having any condition or previous treatment that is known to be a contra-indicated for hyperbaric oxygen therapy.
  3. Pregnant or lactating females.
  4. Candidate with proven macro-vascular compromise who is not eligible for vascular intervention surgery.
  5. Previous treatment with hyperbaric oxygen therapy.
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Responsible Party: King Hamad University Hospital, Bahrain
ClinicalTrials.gov Identifier: NCT03675269    
Other Study ID Numbers: KingHamadUHBahrain
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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