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

NCT03675269 | Withdrawn

• 1 other identifier: KingHamadUHBahrain
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ulcer Foot; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Change in wound size

  The change of wound size at 4 weeks (granulation formation) as measured by the Silhouette three dimensional photography

  4 years

Study Arms (2)

Treatment

EXPERIMENTAL

HBOT

Other: HBOT; Behavioral: Standard wound care

Control

ACTIVE COMPARATOR

Standard wound care

Behavioral: Standard wound care

Interventions

HBOT OTHER

Standard practice

Treatment

Standard wound care BEHAVIORAL

Standard wound care

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender aged \> 18 years.
• Confirmed type 1 or type 2 Diabetes Mellitus patient, currently on anti-diabetic medication
• 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.
• Meeting the selection for HBO criteria as determined by transcutaneous oxygen measurements.
• Willing and able to provide an informed consent for the study and related procedures.

You may not qualify if:

• Lower extremity or foot ulcers of non-diabetic peripheral vascular disease, venous, lymphedematous or neoplastic etiology.
• Having any condition or previous treatment that is known to be a contra-indicated for hyperbaric oxygen therapy.
• Pregnant or lactating females.
• Candidate with proven macro-vascular compromise who is not eligible for vascular intervention surgery.
• Previous treatment with hyperbaric oxygen therapy.

Sponsors & Collaborators

• King Hamad University Hospital, Bahrain: lead
• University of Stellenbosch: collaborator

MeSH Terms

Conditions

Foot Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 18, 2018
• Study Start: September 5, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 28, 2019

Record last verified: 2019-02