N/A
Completed N=73
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
Source: ClinicalTrials.gov NCT02326337 ↗Enrolled (actual)
73
Serious AEs
17.8%
Results posted
Apr 2025
Primary outcomePrimary: Wound Closure Within 12 Weeks With the Use of Topical Wound Oxygen Therapy (TWO2) — 15; 5 Participants
Summary
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care and after meeting all the eligibility criteria, half the subjects will use the TWO2 device, while the other half will use a sham device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Closure Within 12 Weeks With the Use of Topical Wound Oxygen Therapy (TWO2) |
15; 5 | — |
| SECONDARY Absolute Change in Ulcer Area |
1.97; .4 | — |
| SECONDARY Ulcer Recurrence |
1; 2 | — |
| SECONDARY Number of Amputation Events |
2; 3 | — |
| SECONDARY Incidence of Adverse Events |
10; 10; 8; 8; 0; 0 | — |
| SECONDARY Quality of Life Assessment |
9.1; 0.1 | — |
| SECONDARY Economic Analysis |
— | — |
| SECONDARY Time to Complete Wound Closure in Weeks |
8.2; 6.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has a documented diagnosis of Diabetes mellitus Type 1 or 2
- Foot ulcer at or below ankle with duration of more than 4 weeks but no longer than 1 year
- If the index ulcer is a post amputation wound date of surgery must be > 30 days
- 2 week run in period with less than 30% wound size reduction
- University of Texas Grade 1A, 1B, 1C, 1D, 2A, 2B, 2C, or 2D (Appendix I)
- Ulcer is ≥ 1cm2 and ≤ 20cm2 after debridement at start of run-in period
- If more than one ulcer is present on the foot, only the largest is considered in the study (Index ulcer)
- Index ulcer must be ≥ 1cm away from any other ulcers present on the foot
- Adequate perfusion with ABI > 0.7 And TcpO2 > 30mmHg OR skin perfusion > 30mmHG OR Toe pressure > 30mmHg OR Duplex with biphasic waveforms below the knee
- No planned revascularization procedure or vascular surgery within the last/next 30 days
- Subject and/or caregiver are willing and able to comply with all specified care and visit requirements
- Subject has a reasonable expectation of completing the study; according to the Investigator's clinical judgment
Exclusion Criteria
- Evidence of gangrene on any part of affected limb
- Documented evidence of osteomyelitis on any part of affected limb
- Index ulcer has exposed bone
- Index ulcer exhibits signs of severe clinical infection that requires hospitalization or immediate surgical intervention
- Active Charcot foot on the study limb
- Subject participated in another investigational device, drug or biological trial within last 30 days
- Uncontrolled diabetes: HbA1c > 12 %
- Renal dialysis or creatinine > 2.5
- Known immune insufficiency
- Chronic steroid use or immunosuppressive agents within the last three (3) months or is anticipated to require them during the course of the study
- Active treatment for malignancy (not specific to study limb)
- Patient has a Deep Vein Thrombosis within the last 30 days
- Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within the screening period
- Subject may not be pregnant at the time of treatment
Data sourced from ClinicalTrials.gov (NCT02326337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.