Topical Oxygen Therapy for Diabetic Foot Ulcers
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2014 |
| End Date: | June 2017 |
| Contact: | Lauren Allison, RN |
| Email: | lauren.allison@osumc.edu |
| Phone: | 614-366-2783 |
Effects of Topical Oxygen for Diabetic Foot Ulcers
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 foot ulcer(s)
(DFU). 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 foot ulcer (DFU) will be measure and compared with standard of
care (SoC) treatment. There will be a 2 patient groups (including a comparison groups and a
treatment groups) including: (1) Medicaid patients who are at Wagner grade 2 and below, will
only receive standard treatment (2) Medicaid patients who are at Wagner grade 2 and below,
will receive standard treatment plus Topical Oxygen Therapy. All of the Topical Oxygen
Therapy will be provided in a home care setting or extended care facility.100 patients will
be recruited.
This study is 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 DFU at Wagner grades 2 and below who are enrolled in the United Health
Care Community Plan of Ohio (UHC).
healing rate, cost of care and rate of amputations in diabetic patients with foot ulcer(s)
(DFU). 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 foot ulcer (DFU) will be measure and compared with standard of
care (SoC) treatment. There will be a 2 patient groups (including a comparison groups and a
treatment groups) including: (1) Medicaid patients who are at Wagner grade 2 and below, will
only receive standard treatment (2) Medicaid patients who are at Wagner grade 2 and below,
will receive standard treatment plus Topical Oxygen Therapy. All of the Topical Oxygen
Therapy will be provided in a home care setting or extended care facility.100 patients will
be recruited.
This study is 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 DFU at Wagner grades 2 and below who are enrolled in the United Health
Care Community Plan of Ohio (UHC).
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 ulcer 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 in the upper calf. 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.
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 ulcer 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 in the upper calf. 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.
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
- Foot Ulcer
- Ulcer present by history > 4 weeks at time of enrollment
- Compliant with standard wound care regimen
- Wagner grade 1 and 2
- 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
Exclusion Criteria:
- Ulcer in area of radiation treatment.
- Active malignancy at site of ulcer
- 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
We found this trial at
3
sites
Columbus, Ohio 43205
Principal Investigator: Chandan K. Sen, Ph.D.
Phone: 614-366-3751
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Columbus, Ohio 43210
Principal Investigator: Chandan K. Sen, Ph.D.
Phone: 614-247-7657
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Columbus, Ohio 43221
Principal Investigator: Chandan K. Sen, PhD.
Phone: 614-366-2783
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