Topical Oxygen Therapy for Diabetic Wounds

NCT02313428 | Terminated Results DMC FDA Device

• 1 other identifier: 1905092117
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcers; Wound

Keywords

Diabetic Foot Ulcer; Topical Oxygen Therapy; Medicaid Recipients; Standard of Care; Diabetic Wounds

Outcome Measures

Primary Outcomes (1)

• Change in Wound Closure

  Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care

  baseline and 16 weeks

Secondary Outcomes (4)

• Rate of Amputations

  16 weeks

• Complication Rate

  16 weeks

• Cost of Care

  16 weeks

• Quality of Life for Subjects- SF-36

  16 weeks

Study Arms (2)

Standard of Care with Topical Oxygen Treatment

EXPERIMENTAL

patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities).

Device: Topical Oxygen Chamber for Extremities

Standard of Care only

NO INTERVENTION

patients that have a chronic wound will receive only their standard of care treatment.

Interventions

Topical Oxygen Chamber for Extremities DEVICE

Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers

Also known as: Topical Oxygen Device

Standard of Care with Topical Oxygen Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (11)

• 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.

  PMID: 4184490 BACKGROUND

• 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.

  PMID: 18430064 BACKGROUND

• Heng MCY, Pilgrim JP and Beck FWJ. A simplified technique for hyperbaric oxygen administration for leg ulcers. Clin Res 1982, 30:262A.

  BACKGROUND

• Heng MC, Pilgrim JP, Beck FW. A simplified hyperbaric oxygen technique for leg ulcers. Arch Dermatol. 1984 May;120(5):640-5.

  PMID: 6721526 BACKGROUND

• 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.

  PMID: 14567939 BACKGROUND

• Proposed Rule -General and Plastic Surgery Devices; General Provisions and Classification of 54 Devices, 47 Fed. Reg. 2810-2853 (Jan. 19, 1982).

  BACKGROUND

• Final Rule -General and Plastic Surgery Devices; General Provisions and Classification of 51 Devices, 53 Fed. Reg. 23856, 23869-23870 (June 24, 1988).

  BACKGROUND

• 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.

  PMID: 21516875 BACKGROUND

• 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.

  PMID: 10788918 BACKGROUND

• 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.

  PMID: 11189538 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Sashwati Roy
• Organization: University of Pittsburgh

sar543@pitt.edu

412-648-8297

Study Officials

• Chandan K. Sen, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Vice President of Research

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: February 1, 2020
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2021
• Last Updated: April 25, 2024
• Results First Posted: April 25, 2024

Record last verified: 2024-04

Locations

US (1)