NCT02313428|TerminatedResultsDMCFDA Device
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Recruitment unfulfilled due to lack of staffing.
Effects of Topical Oxygen for Diabetic Wounds
Sponsor study identifier
interventional
4
1 country
1
Study Start
February 1, 2020
Actual (reported)Primary Completion
August 5, 2021
Actual (reported)Study Completion
August 5, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 5, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2014
Actual (reported)December 10, 2014
Actual (reported)February 1, 2020
Actual (reported)August 5, 2021
Actual (reported)August 5, 2021
Actual (reported)April 25, 2024
Actual (reported)Change in Wound Closure
Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care
baseline and 16 weeks
Rate of Amputations
16 weeks
Complication Rate
16 weeks
Cost of Care
16 weeks
Quality of Life for Subjects- SF-36
16 weeks
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.
Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
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.
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.
Chandan K. Sen, PhD
Indiana University
4 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2014
First Posted
December 10, 2014
Study Start
February 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Heng MCY, Pilgrim JP and Beck FWJ. A simplified technique for hyperbaric oxygen administration for leg ulcers. Clin Res 1982, 30:262A.
Heng MC, Pilgrim JP, Beck FW. A simplified hyperbaric oxygen technique for leg ulcers. Arch Dermatol. 1984 May;120(5):640-5.
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.
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).
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.
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.
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.
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.
Primary Completion
August 5, 2021
Actual (reported)Study Completion
August 5, 2021
Actual (reported)Last Updated
April 25, 2024
Results First Posted
April 25, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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