Topical Oxygen Therapy for Diabetic Wounds
Primary Purpose
Diabetic Foot Ulcers, Wound
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topical Oxygen Chamber for Extremities
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Diabetic Foot Ulcer, Topical Oxygen Therapy, Medicaid Recipients, Standard of Care, Diabetic Wounds
Eligibility 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
- -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:
- Debridement of infected bone if necessary
- Patient has received at least 2 weeks of appropriate antibiotics
- ABI < 0.7 or > 1.2
Sites / Locations
- IU Health Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Standard of Care with Topical Oxygen Treatment
Standard of Care only
Arm Description
patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities).
patients that have a chronic wound will receive only their standard of care treatment.
Outcomes
Primary Outcome Measures
Wound Closure
Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care
Secondary Outcome Measures
Rate of amputations
Amputations rates 16 weeks of Topical Oxygen Therapy or Standard of Care
Complication Rate
Complication rates (infection) at 16 weeks of Topical Oxygen Therapy or Standard of Care
Cost of Care
Post-test health expenditures at 16 weeks of Topical Oxygen Therapy or Standard of Care
Quality of Life for subjects- SF-36
QoL data at 16 weeks of Topical Oxygen Therapy or Standard of Care
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02313428
Brief Title
Topical Oxygen Therapy for Diabetic Wounds
Official Title
Effects of Topical Oxygen for Diabetic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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. Eleven subjects were enrolled at The Ohio State University; we intend to enroll 29 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers, Wound
Keywords
Diabetic Foot Ulcer, Topical Oxygen Therapy, Medicaid Recipients, Standard of Care, Diabetic Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care with Topical Oxygen Treatment
Arm Type
Experimental
Arm Description
patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities).
Arm Title
Standard of Care only
Arm Type
No Intervention
Arm Description
patients that have a chronic wound will receive only their standard of care treatment.
Intervention Type
Device
Intervention Name(s)
Topical Oxygen Chamber for Extremities
Other Intervention Name(s)
Topical Oxygen Device
Intervention Description
Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers
Primary Outcome Measure Information:
Title
Wound Closure
Description
Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Rate of amputations
Description
Amputations rates 16 weeks of Topical Oxygen Therapy or Standard of Care
Time Frame
16 weeks
Title
Complication Rate
Description
Complication rates (infection) at 16 weeks of Topical Oxygen Therapy or Standard of Care
Time Frame
16 weeks
Title
Cost of Care
Description
Post-test health expenditures at 16 weeks of Topical Oxygen Therapy or Standard of Care
Time Frame
16 weeks
Title
Quality of Life for subjects- SF-36
Description
QoL data at 16 weeks of Topical Oxygen Therapy or Standard of Care
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
-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:
Debridement of infected bone if necessary
Patient has received at least 2 weeks of appropriate antibiotics
ABI < 0.7 or > 1.2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandan K. Sen, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
4184490
Citation
Fischer BH. Topical hyperbaric oxygen treatment of pressure sores and skin ulcers. Lancet. 1969 Aug 23;2(7617):405-9. doi: 10.1016/s0140-6736(69)90113-5. No abstract available.
Results Reference
background
Citation
Heng MCY, Pilgrim JP and Beck FWJ. A simplified technique for hyperbaric oxygen administration for leg ulcers. Clin Res 1982, 30:262A.
Results Reference
background
PubMed Identifier
6721526
Citation
Heng MC, Pilgrim JP, Beck FW. A simplified hyperbaric oxygen technique for leg ulcers. Arch Dermatol. 1984 May;120(5):640-5.
Results Reference
background
Citation
Proposed Rule -General and Plastic Surgery Devices; General Provisions and Classification of 54 Devices, 47 Fed. Reg. 2810-2853 (Jan. 19, 1982).
Results Reference
background
Citation
Final Rule -General and Plastic Surgery Devices; General Provisions and Classification of 51 Devices, 53 Fed. Reg. 23856, 23869-23870 (June 24, 1988).
Results Reference
background
PubMed Identifier
21516875
Citation
Food and Drug Administration, HHS. Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule. Fed Regist. 2011 Apr 25;76(79):22805-7.
Results Reference
background
PubMed Identifier
10788918
Citation
Heng MC, Harker J, Bardakjian VB, Ayvazian H. Enhanced healing and cost-effectiveness of low-pressure oxygen therapy in healing necrotic wounds: a feasibility study of technology transfer. Ostomy Wound Manage. 2000 Mar;46(3):52-60, 62.
Results Reference
background
PubMed Identifier
11189538
Citation
Heng MC, Harker J, Csathy G, Marshall C, Brazier J, Sumampong S, Paterno Gomez E. Angiogenesis in necrotic ulcers treated with hyperbaric oxygen. Ostomy Wound Manage. 2000 Sep;46(9):18-28, 30-2.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18430064
Citation
Gordillo GM, Roy S, Khanna S, Schlanger R, Khandelwal S, Phillips G, Sen CK. Topical oxygen therapy induces vascular endothelial growth factor expression and improves closure of clinically presented chronic wounds. Clin Exp Pharmacol Physiol. 2008 Aug;35(8):957-64. doi: 10.1111/j.1440-1681.2008.04934.x. Epub 2008 Apr 21.
Results Reference
result
PubMed Identifier
14567939
Citation
Kalliainen LK, Gordillo GM, Schlanger R, Sen CK. Topical oxygen as an adjunct to wound healing: a clinical case series. Pathophysiology. 2003 Jan;9(2):81-87. doi: 10.1016/s0928-4680(02)00079-2.
Results Reference
result
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Topical Oxygen Therapy for Diabetic Wounds
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