N/A
N=145
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
Diabetic Foot Ulcer · Surgical Wound
Bottom Line
View on ClinicalTrials.gov: NCT03905863 ↗Enrolled (actual)
145
Serious AEs
9.7%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants That Achieve Complete Wound Closure During the Twelve Week Study and the Percentage Change in Participant Ulcer Size at 12 Weeks From Baseline. — 18; 36; 18; 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Natrox® Oxygen Wound Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Inotec AMD Limited
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Achieve Complete Wound Closure During the Twelve Week Study and the Percentage Change in Participant Ulcer Size at 12 Weeks From Baseline. |
18; 36; 18; 36 | — |
| PRIMARY Percentage Reduction in Ulcer Area (cm^2). |
41.05; 46.38; 40.44; 70.18 | — |
| SECONDARY Level of Pain of the Wound |
2.02; 1.81; 0.68; 0.95 | — |
| SECONDARY Number of Adverse Events |
32; 41; 30; 37; 1; 2 | — |
Summary
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
Eligibility Criteria
Inclusion Criteria
- Subjects are male or female, 18 years of age or older. At least 50% of the enrolled population must be ≥ 65 years of age.
- Subjects with one of the following wounds:
A. Diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
B. Minor amputation wound sites
- Subject has clinical documentation of no visible wound improvement in the after 4 weeks of standard of care. Objectively, less than 40% healing in the past four weeks from the first treatment visit.
- Study ulcer is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
- Subjects' wound score on ISDA tool is Grade 1 or 2.
- The subject is able and willing to follow the protocol requirements
- Subject has signed informed consent
- Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of >6 within 3 months of the first Screening Visit.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- The target ulcer has been offloaded for at least 14 days prior to randomization.
Exclusion Criteria
- Subject has a known life expectancy of 10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first treatment visit.
- Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.
- Known HbA1C >12%
- An ulcer that has visible signs of improvement in the four weeks prior to randomization defined objectively as a 40% reduction in surface area in the four weeks prior to enrollment.
- An ulcer that has healed by more than 20% in the 2 weeks prior to screening: "historical" run-in period.
Data sourced from ClinicalTrials.gov (NCT03905863). 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.