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

Diabetic Foot Ulcer Clinical Trial

Official title:

A Randomized Controlled Multicentre Trial, Examining the Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905863
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Surgical Wound
• Ulcer
• Wounds and Injuries

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