The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers

Not Applicable

Completed

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

Detailed 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 & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Intervention arm	Natrox® Oxygen Wound Therapy	Same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® OG and the Natrox® ODS. The OG is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The ODS is a sterile, single use device that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the OG via a thin flexible fine-bore tube. While the ODS can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory.

Primary Outcome Measures

Name	Time	Method
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.	Twelve (12) weeks from Time 0	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.
Percentage Reduction in Ulcer Area (cm^2).	Twelve (12) weeks from Time 0	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.

Secondary Outcome Measures

Name	Time	Method
Level of Pain of the Wound	Up to twelve (12) weeks from Time 0	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.
Number of Adverse Events	Up to twelve (12) weeks from time 0	Number of adverse events, such as infections, that are found associated with the study wound

Locations (20): New Hope Podiatry Clinic
🇺🇸
Los Angeles, California, United States
MedCare Research
🇺🇸
Miami, Florida, United States
Pinnacle Foot and Ankle Center
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Houston, Texas, United States
El Campo Memorial Hospital
🇺🇸
El Campo, Texas, United States
San Marcus Research Clinic
🇺🇸
Miami Lakes, Florida, United States
ACMH Snyder Institute
🇺🇸
Kittanning, Pennsylvania, United States
Wahab Consulting and Research
🇺🇸
Las Vegas, Nevada, United States
Allure Health LLC
🇺🇸
Friendswood, Texas, United States
SerenaGroup Research Institute
🇺🇸
Pittsburgh, Pennsylvania, United States
Barry University Clinical Research
🇺🇸
North Miami Beach, Florida, United States
Doctors Research Network
🇺🇸
South Miami, Florida, United States
Antria
🇺🇸
Indiana, Pennsylvania, United States
Royal Research Corp
🇺🇸
Pembroke Pines, Florida, United States
Cleveland Foot and Ankle Clinic
🇺🇸
Cleveland, Ohio, United States
Mercury Clinical Research
🇺🇸
Webster, Texas, United States
Tulsa Bone and Joint
🇺🇸
Tulsa, Oklahoma, United States
Global Health Research Center Inc
🇺🇸
Miami Lakes, Florida, United States
Pharma Research Associates
🇺🇸
Westchester, Florida, United States
The Foot and Ankle Wellness Center of Western Pennsylvania
🇺🇸
Ford City, Pennsylvania, United States
Clinical Research Management Group
🇵🇷
Coto Laurel, Puerto Rico