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Topical Oxygen Therapy for Diabetic Wounds

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ClinicalTrials.gov Identifier: NCT02313428
Recruitment Status : Unknown
Verified August 2017 by Chandan K Sen, Ohio State University.
Recruitment status was:  Recruiting
First Posted : December 10, 2014
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Ohio Department of Medicaid
Information provided by (Responsible Party):
Chandan K Sen, Ohio State University

Brief Summary:

This study is to observe the effect of application of topically administered oxygen on healing rate, cost of care and rate of amputations in diabetic patients with chronic wounds(s) . The proposed study is a pragmatic (comparative effectiveness research, CER) study, in which the effectiveness of topical oxygen (100%) administered 4 days per week, for 16 weeks, for the treatment of diabetic wound(s) will be measure and compared with standard of care (SoC) treatment. There will be a 2 patient groups (including a comparison group and a treatment group) including: (1) Patients will only receive standard treatment (2) Patients will receive standard treatment plus Topical Oxygen Therapy (TOT). All of the Topical Oxygen Therapy will be provided in a home care setting or extended care facility. 140 patients will be recruited.

There are two arms of the study. Arm 1 will enroll 100 subjects to assist the Ohio Department of Medicaid (ODM) and to provide efficient and effective administration of the Medicaid program. This is an observational and descriptive study that will seek to generate a hypothesis. 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 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. The patient population will consist of Medicaid beneficiaries with chronic wounds and below who are enrolled in the United Health Care Community Plan of Ohio (UHC).

Arm 2 of the study will enroll 40 additional patients that are Medicare and Dual Medicare/Medicaid recipients with chronic wounds.


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 DFU that is input into WoundMatrix™ software, and the patient will be asked to complete a quality of life questionnaire. They will also be provided with teaching regarding diabetes, footwear, and wound care. 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 and at study visit 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). The patient will have the study personnel come to their home to provide supplies, teach, and give support for the TO device. The study personnel will also go to the patient's home weekly to give support for the treatments.

Participation in this study is expected to add no additional risk to the patient. The only risk expected to occur with any frequency is irritation of the skin while applying the TOT bag. This issue is anticipated in the protocol, which specifies appropriate treatment modifications and discontinuation of Topical Oxygen, if the problem does not improve. This problem, if it 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 in which 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.

The potential benefits however are dramatic. The disease state is highly morbid and typically involves prolonged medical care and multiple surgical procedures. Despite intensive therapeutic intervention the state of the art still results in high morbidity and mortality at a high financial cost. 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. Patients enrolled in the comparison groups will benefit by close follow-up and treatment using accepted comprehensive wound cares protocol.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effects of Topical Oxygen for Diabetic Wounds
Study Start Date : December 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ohio Department of Medicaid
Medicaid patients who have a chronic wound, will be randomized to either receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities) or only their standard of care treatment
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

Experimental: Medicare and Dual Medicare/Medicaid
Medicare and Dual Medicare/Medicaid patients who have a chronic wound, will be randomized to either receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities) or only their standard of care treatment
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




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 Wagner grade and 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 for the wound will be assessed after 16 weeks of Topical Oxygen Therapy or Standard of Care.

  3. Amputation Rates [ Time Frame: 2 years ]
    Rate of amputation after subject enrollment has been completed.

  4. Hospital admission rate [ Time Frame: 2 years ]
    Hospital admission rates will be assessed after subject enrollment has been completed.

  5. Post-test health care expenditures [ Time Frame: 2 years ]
    Post-test health expenditures will be assessed after subject enrollment has been completed.



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:

  • 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 Recipient (Arm 1 or Medicare / Dual Medicare / Medicaid Recipient Arm 2)
  • 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, but NOT able to obtain hyperbaric oxygen therapy
  • 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) 0.5 to 1.3
  • If ABI non-compressible (ABI >1.3), 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

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 ClinicalTrials.gov identifier (NCT number): NCT02313428


Contacts
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Contact: Amy Hoover, LPN 614-293-0390 amy.hoover@osumc.edu
Contact: Elizabeth Murphy, BS 614-685-3173 elizabeth.murphy@osumc.edu

Locations
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United States, Ohio
Davis Heart and Lung Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Sashwati Roy, Ph.D    614-247-7657    sashwati.roy@osumc.edu   
Contact: Amy Hoover, LPN    614-685-3173    Amy.Hoover@osumc.edu   
Principal Investigator: Chandan K. Sen, Ph.D.         
Amy Hoover, LPN Recruiting
Columbus, Ohio, United States, 43221
Contact: Amy H Hoover, LPN    614-293-0390    Amy.Hoover@osumc.edu   
Contact: Samir Zaparde, MD    614-685-3173    Samir.Zaparde@osumc.edu   
Principal Investigator: Chandan K. Sen, PhD.         
Amy Hoover Recruiting
Columbus, Ohio, United States, 43221
Contact: Amy H Hoover, RN    614-293-0390    Amy.Hoover@osumc.edu   
Contact: Samir Zaparde, MD    614-685-3173    samir.zaparde@osumc.edu   
Principal Investigator: Chandan K. Sen, Ph.D.         
Sponsors and Collaborators
Ohio State University
Ohio Department of Medicaid
Investigators
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Principal Investigator: Chandan K. Sen, Ph.D Ohio State University

Publications of Results:
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Responsible Party: Chandan K Sen, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02313428     History of Changes
Other Study ID Numbers: 2014H0342
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

Keywords provided by Chandan K Sen, Ohio State University:
Diabetic Foot Ulcer
Topical Oxygen Therapy
Medicaid Recipients
Standard of Care
Diabetic Wounds

Additional relevant MeSH terms:
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Wounds and Injuries
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases