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Topical Oxygen Therapy for Diabetic Wounds

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02313428
Recruitment Status : Recruiting
First Posted : December 10, 2014
Last Update Posted : April 7, 2020
Information provided by (Responsible Party):
Chandan Sen, Indiana University

Brief Summary:
This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial. Twenty-four subjects were enrolled at The Ohio State University; we intend to enroll 16 more subjects at Indiana University. Due to the small sample size this study will primarily be a feasibility study that will attempt to measure and evaluate differences in the relative theoretical costs of the intervention of topical oxygen therapy on this population and subsequently compare outcomes in areas such as overall health improvements and cost effectiveness.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Wound Device: Topical Oxygen Chamber for Extremities Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Wound Closure [ Time Frame: 16 weeks ]
    Wound Closure will be assessed after 16 weeks of Topical Oxygen Therapy or Standard of Care

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Cost of Care [ Time Frame: 16 weeks ]
    Post-test health expenditures will be assessed after subject enrollment has been completed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Age >18 years
  • Able to give informed consent, willing and able to visit the hospital and CWC for regular treatment and follow-up visits.
  • Diabetic
  • Medicaid or Medicare or dual eligible
  • Chronic wound OR Foot Ulcer:
  • Ulcer present by history > 4 weeks at time of enrollment
  • Compliant with standard wound care regimen
  • IF foot wound, Wagner grade 1 and 2, OR Wagner grade 3
  • Ulcer size: 0.6 cm2 to 20 cm2 and has not decreased in size by more than 30% in previous 2 weeks of the enrollment visit
  • Adequate circulatory status, as evidenced by any of the following:
  • Ankle Brachial Index (ABI) >0.7 - < 1.20
  • If ABI non-compressible (ABI >1.2), then toe brachial Index (TBI)>0.5
  • SPP > 30mmHg
  • TcOM > 30mmHg
  • At least 4 weeks since revascularization procedure, if one has been performed
  • Able to complete Topical Oxygen Therapy 4 day/week for 16 weeks (must be able to remove existing wound dressing and apply TO2 Boot/treatment, and then re-dress wound)

Exclusion Criteria:

  • Ulcer in area of radiation treatment.
  • Active malignancy at site of ulcer
  • Current treatment with wound VAC or weekly compression dressing
  • Untreated infection at site of ulcer (i.e. cellulitis or osteomyelitis)
  • If acute osteomyelitis has been diagnosed, patient may be enrolled only after the infection has been controlled. Including:

    1. Debridement of infected bone if necessary
    2. Patient has received at least 2 weeks of appropriate antibiotics
  • ABI < 0.7 or > 1.2

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 identifier (NCT number): NCT02313428

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Contact: Jennifer Mohnacky, RDN (317) 278-2715
Contact: Tammy Garrett, RN (317) 278-2716

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United States, Indiana
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Mohnacky, RDN    317-278-2715   
Contact: Tammy Garrett, RN    (317) 278-2716   
Sub-Investigator: Sashwati Roy, PhD         
Sub-Investigator: Gayle Gordillo, MD         
Sponsors and Collaborators
Indiana University
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Principal Investigator: Chandan K. Sen, PhD Indiana University
Publications of Results:
Other Publications:
Heng MCY, Pilgrim JP and Beck FWJ. A simplified technique for hyperbaric oxygen administration for leg ulcers. Clin Res 1982, 30:262A.
Proposed Rule -General and Plastic Surgery Devices; General Provisions and Classification of 54 Devices, 47 Fed. Reg. 2810-2853 (Jan. 19, 1982).
Final Rule -General and Plastic Surgery Devices; General Provisions and Classification of 51 Devices, 53 Fed. Reg. 23856, 23869-23870 (June 24, 1988).
Ware, J.E., Snow, K.K., Kolinski, M., Gandeck, B., 1993. SF-36 Health survey manual and interpretation guide. The Health Institute, New England Medical Centre, Boston, MA.

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Responsible Party: Chandan Sen, Associate Vice President of Research, Indiana University Identifier: NCT02313428    
Other Study ID Numbers: 1905092117
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Chandan Sen, Indiana University:
Diabetic Foot Ulcer
Topical Oxygen Therapy
Medicaid Recipients
Standard of Care
Diabetic Wounds
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Wounds and Injuries
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases