Topical Oxygen Therapy for Diabetic Wounds
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|ClinicalTrials.gov Identifier: NCT02313428|
Recruitment Status : Recruiting
First Posted : December 10, 2014
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers Wound||Device: Topical Oxygen Chamber for Extremities||Not Applicable|
There are a total of 5 study visits including the initial baseline visit were they will be randomized into one of the 2 groups (comparison or treatment). At the baseline visit the following will be collected; history of the patient, physical examination of the patient including:, digital imaging of the diabetic foot ulcer (DFU) or chronic wound that is input into the WoundMatrix™ software, and the patient will be asked to complete a quality of life questionnaire. Patients will be provided with education regarding diabetes, footwear, and wound care. They will also be given a diary to log their treatments. Patients will return for study visits 2-5 on weeks 4, 8, 12, 16. At study visit 2-5 the research staff will collect digital imaging of the ulcer, review medication, collect previous diary and distribute a new one, and note any wound or health complications. At study visits 1 and 5, the patient will be asked to complete the quality of life questionnaire. These visits will be correlated with their regular scheduled visit at the CWC. If their wound heals before the end of the study, they will be asked to return for study visit 5 (week 16). The patient will complete the at home treatments, including the 90 minute treatment, 4 consecutive days a week, 3 day of no treatment). Study personnel will provide supplies, teach, and give support for the TO device. The study personnel will contact the subject weekly to give support for the treatments.
Participation in this study is expected to add no additional risk to the patient. There is a low risk of local irritation of the skin from application of the Topical Oxygen device for those in the Topical Oxygen Therapy group. This issue is anticipated in the protocol, which specifies appropriate treatment modifications and discontinuation of Topical Oxygen, if it does not improve. If this problem occurs, is expected to be self-limited and of minor significance. Oxygen, although not combustible itself, supports combustion of other flammable materials. The use of oxygen in this protocol is essentially equivalent to that supplied by nasal cannula to patients in hospital or at home. To minimize the risk of fire, the investigators will strictly enforce a 'no smoking' and 'no open flame' policy in any room where Topical Oxygen is utilized. Treatment facilities will comply with local fire ordinances and study personnel will be familiar with fire safety protocols of each facility.
Participants may or may not experience directly benefit from participating in this study. The disease state is highly morbid and typically involves prolonged medical care and multiple surgical procedures. Participants may experience improved healing of their wound as a result of their participation in this study, but there is no guarantee of this. Patients enrolled in the study may also benefit from the close follow-up with study staff and compliance with wound treatment. In addition, the information learned from this research study may lead to a better understanding of diabetic wounds and how they heal, which could lead to better treatment options for patients with diabetic wounds in the future. The application of topical oxygen to diabetic wounds has the potential to dramatically impact the effectiveness of wound healing and to therefore improve limb salvage, decrease infection rates and mortality, and generally improve the quality of life of study participants receiving topical oxygen as well as the general population if efficacy is proved.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Topical Oxygen for Diabetic Wounds|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2022|
Experimental: Standard of Care with Topical Oxygen Treatment
Medicaid and Dual Medicare/Medicaid patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities).
Device: Topical Oxygen Chamber for Extremities
Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers
Other Name: Topical Oxygen Device
No Intervention: Standard of Care only
Medicare and Dual Medicare/Medicaid patients that have a chronic wound will receive only their standard of care treatment.
- Wound Closure [ Time Frame: 16 weeks ]Wound Closure will be assessed after 16 weeks of Topical Oxygen Therapy or Standard of Care
- Healing Rate [ Time Frame: 16 weeks ]Healing rate including wound size, will be assessed after 16 weeks of Topical Oxygen Therapy or Standard of Care
- Complication Rate [ Time Frame: 16 weeks ]Complication rates (infection, amputation) for the wound will be assessed after 16 weeks of Topical Oxygen Therapy or Standard of Care.
- Cost of Care [ Time Frame: 16 weeks ]Post-test health expenditures will be assessed after subject enrollment has been completed.
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): NCT02313428
|Contact: Jennifer Mohnacky, RDN||(317) email@example.com|
|Contact: Tammy Garrett, RN||(317) firstname.lastname@example.org|
|United States, Indiana|
|IU Health Methodist Hospital||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Jennifer Mohnacky, RDN 317-278-2715 email@example.com|
|Contact: Tammy Garrett, RN (317) 278-2716 firstname.lastname@example.org|
|Sub-Investigator: Sashwati Roy, PhD|
|Sub-Investigator: Gayle Gordillo, MD|
|Principal Investigator:||Chandan K. Sen, PhD||Indiana University|