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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03905863
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 4, 2019
Est. completion date October 18, 2020

Study information

Verified date November 2021
Source Inotec AMD Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.


Description:

Patients with diabetic foot ulcers will be enrolled into the trial at multiple wound care centers and hospital research centers across the United States of America. After qualifying per protocol, patients will be randomized to receive standard wound care or standard wound care plus Topical Oxygen Wound Therapy for their wounds. Patients will be monitored for 12 weeks. The primary comparator between the groups will be complete wound healing at 12 weeks, but other parameters will be assessed, such as pain, wound size reduction and infection status.


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date October 18, 2020
Est. primary completion date October 18, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria 1. Subjects are male or female, 18 years of age or older. At least 50% of the enrolled population must be = 65 years of age. 2. 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 3. 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. 4. Study ulcer is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit 5. Subjects' wound score on ISDA tool is Grade 1 or 2. 6. The subject is able and willing to follow the protocol requirements 7. Subject has signed informed consent 8. 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. 9. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). 10. The target ulcer has been offloaded for at least 14 days prior to randomization. Exclusion Criteria 1. Subject has a known life expectancy of < 1 year 2. Subject or caregiver is unable to manage the Natrox® device (charge and change batteries daily) 3. Subject has ulcers that are completely necrotic or if the clinician feels it is clinically necessary to cover the wound surface in gel or creams that would prevent the transmission of oxygen to the wound surface. 4. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia. 5. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound. 6. The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety 7. Known contraindications for the Natrox system 8. Known allergies to any of the Natrox system components 9. Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study. 10. Index ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization visit. 11. Subject is pregnant or breast feeding. 12. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >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. 13. 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. 14. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1. 15. Known HbA1C >12% 16. 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. 17. An ulcer that has healed by more than 20% in the 2 weeks prior to screening: "historical" run-in period.

Study Design


Intervention

Device:
Natrox® Oxygen Wound Therapy
A battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.

Locations

Country Name City State
Puerto Rico Clinical Research Management Group Coto Laurel
United States Cleveland Foot and Ankle Clinic Cleveland Ohio
United States El Campo Memorial Hospital El Campo Texas
United States The Foot and Ankle Wellness Center of Western Pennsylvania Ford City Pennsylvania
United States Allure Health LLC Friendswood Texas
United States Pinnacle Foot and Ankle Center Houston Texas
United States Antria Indiana Pennsylvania
United States ACMH Snyder Institute Kittanning Pennsylvania
United States Wahab Consulting and Research Las Vegas Nevada
United States New Hope Podiatry Clinic Los Angeles California
United States MedCare Research Miami Florida
United States Global Health Research Center Inc Miami Lakes Florida
United States San Marcus Research Clinic Miami Lakes Florida
United States Barry University Clinical Research North Miami Beach Florida
United States Royal Research Corp Pembroke Pines Florida
United States SerenaGroup Research Institute Pittsburgh Pennsylvania
United States Doctors Research Network South Miami Florida
United States Tulsa Bone and Joint Tulsa Oklahoma
United States Mercury Clinical Research Webster Texas
United States Pharma Research Associates Westchester Florida

Sponsors (2)

Lead Sponsor Collaborator
Inotec AMD Limited SerenaGroup, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
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. Photographic wound evaluation and measurements were conducted utilizing an AI-driven computerized planimetry imaging system (Tissue Analytics, Inc., Baltimore, MD USA).15 This system obtained both 2D and 3D assessments of the wound at each visit through a standardized mobile device; in addition, the lead investigator reviewed all digital images. Twelve (12) weeks from Time 0
Primary Percentage Reduction in Ulcer Area (cm^2). Wound size change over time using a wound imaging measurement system. Percentage change in ulcer area was calculated on the basis of area change from the start of the study to the final recorded value. Any healed ulcer was recorded as having achieved 100% reduction in area; positive values indicate a reduction in size over the 12-week period while negative values indicate that the ulcer increased in size. Twelve (12) weeks from Time 0
Secondary Level of Pain of the Wound Does pain associated with the wound change over time using a Visual Analogue Scale Pain intensity of the reference DFU is to be assessed before any dressing changes or other ulcer manipulations at all screening and treatment visits.
Subject will be asked to indicate a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "worst possible pain" on the right side of the number line. The number 0 represent "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain". The subject indicates the level of pain intensity by selecting a number on the line that represents their perception of their current state.
Up to twelve (12) weeks from Time 0
Secondary Number of Adverse Events Number of adverse events, such as infections, that are found associated with the study wound Up to twelve (12) weeks from time 0
See also
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