Clinical trial NCT02313428: Topical Oxygen Therapy for Diabetic Wounds
Official title: Effects of Topical Oxygen for Diabetic Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcers
Wound
Keywords: Diabetic Foot Ulcer
Topical Oxygen Therapy
Medicaid Recipients
Standard of Care
Diabetic Wounds
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Change in Wound Closure
timeFrame: baseline and 16 weeks
Secondary outcomes:
measure: Rate of Amputations
timeFrame: 16 weeks
measure: Complication Rate
timeFrame: 16 weeks
measure: Cost of Care
timeFrame: 16 weeks
measure: Quality of Life for Subjects- SF-36
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Chandan K. Sen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Heng MCY, Pilgrim JP and Beck FWJ. A simplified technique for hyperbaric oxygen administration for leg ulcers. Clin Res 1982, 30:262A.
citation: Heng MC, Pilgrim JP, Beck FW. A simplified hyperbaric oxygen technique for leg ulcers. Arch Dermatol. 1984 May;120(5):640-5.
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.
citation: Proposed Rule -General and Plastic Surgery Devices; General Provisions and Classification of 54 Devices, 47 Fed. Reg. 2810-2853 (Jan. 19, 1982).
citation: Final Rule -General and Plastic Surgery Devices; General Provisions and Classification of 51 Devices, 53 Fed. Reg. 23856, 23869-23870 (June 24, 1988).
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.
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.
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.
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.