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

NCT03905863 | Completed Results FDA Device

• 1 other identifier: 1
• Study Type: interventional
• Target: 145
• Locations: 2 countries
• Sites: 20

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.

Conditions

Diabetic Foot Ulcer; Surgical Wound

Keywords

topical oxygen; topical oxygen treatment; diabetic foot ulcer; non-healing wound; surgical site; pain; wound size; healing; infection

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Level of Pain of the Wound

  Up to twelve (12) weeks from Time 0

• Number of Adverse Events

  Up to twelve (12) weeks from time 0

Study Arms (2)

Standard of care arm

NO INTERVENTION

SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardised protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection.

Intervention arm

ACTIVE COMPARATOR

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.

Device: Natrox® Oxygen Wound Therapy

Interventions

Natrox® Oxygen Wound Therapy DEVICE

A battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subject has a known life expectancy of \< 1 year
• Subject or caregiver is unable to manage the Natrox® device (charge and change batteries daily)
• 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.
• Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
• Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
• The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety
• Known contraindications for the Natrox system
• Known allergies to any of the Natrox system components
• Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
• 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.
• Subject is pregnant or breast feeding.
• 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.
• 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%

Sponsors & Collaborators

• Inotec AMD Limited: lead
• SerenaGroup, Inc.: collaborator

Study Sites (20)

New Hope Podiatry Clinic

Los Angeles, California, 90063, United States

Location

MedCare Research

Miami, Florida, 33165, United States

Location

San Marcus Research Clinic

Miami Lakes, Florida, 33014, United States

Location

Global Health Research Center Inc

Miami Lakes, Florida, 33016, United States

Location

Barry University Clinical Research

North Miami Beach, Florida, 44169, United States

Location

Royal Research Corp

Pembroke Pines, Florida, 33027, United States

Location

Doctors Research Network

South Miami, Florida, 33143, United States

Location

Pharma Research Associates

Westchester, Florida, 33155, United States

Location

Wahab Consulting and Research

Las Vegas, Nevada, 89148, United States

Location

Cleveland Foot and Ankle Clinic

Cleveland, Ohio, 44103, United States

Location

Tulsa Bone and Joint

Tulsa, Oklahoma, 74146, United States

Location

The Foot and Ankle Wellness Center of Western Pennsylvania

Ford City, Pennsylvania, 16226, United States

Location

Antria

Indiana, Pennsylvania, 15701, United States

Location

ACMH Snyder Institute

Kittanning, Pennsylvania, 16201, United States

Location

SerenaGroup Research Institute

Pittsburgh, Pennsylvania, 15222, United States

Location

El Campo Memorial Hospital

El Campo, Texas, 77437, United States

Location

Allure Health LLC

Friendswood, Texas, 77546, United States

Location

Pinnacle Foot and Ankle Center

Houston, Texas, 77054, United States

Location

Mercury Clinical Research

Webster, Texas, 77598, United States

Location

Clinical Research Management Group

Coto Laurel, Ponce, 00780, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic Foot; Surgical Wound; Pain; Infections

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Thomas Serena
• Organization: Serena Group Inc

serena@serenagroups.com

671-945-5225

Study Officials

• Thomas Serena

  SerenaGroup, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: June 4, 2019
• Primary Completion: October 18, 2020
• Study Completion: October 18, 2020
• Last Updated: November 22, 2021
• Results First Posted: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); PR (1)