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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03905863
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : February 23, 2021
SerenaGroup, Inc.
Information provided by (Responsible Party):
Inotec AMD Limited

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Surgical Wound Device: Natrox® Oxygen Wound Therapy Not Applicable

Detailed Description:
Approximately 132 patients with Diabetic Foot Ulcers will be enrolled into the trial at fifteen Wound Care Centers and Hospitals across the United States of America. Patients will be selected to receive standard wound care or standard wound care plus Natrox 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Multicentre Trial, Examining the Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
Actual Study Start Date : June 4, 2019
Actual Primary Completion Date : October 18, 2020
Actual Study Completion Date : October 18, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Standard of care arm
Patients in the standard of care arm will receive the standard care for their type of wound from their wound care centre.
Active Comparator: Intervention arm
Patients in the intervention arm will receive standard of care plus Natrox® Oxygen Wound Therapy as treatment for their wound.
Device: Natrox® Oxygen Wound Therapy
A battery-operated device which delivers 98% pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.

Primary Outcome Measures :
  1. Percentage of wounds that heal [ Time Frame: Twelve (12) weeks from Time 0 ]
    Wounds will be visually assessed by clinicians as healed or not healed

  2. Wound size change [ Time Frame: Twelve (12) weeks from Time 0 ]
    Wound size change over time using a wound imaging measurement system

Secondary Outcome Measures :
  1. Arbitrary scale of ease of implementation of Natrox® [ Time Frame: Twelve (12) weeks from Time 0 ]

    Questionnaire to assess how easy or difficult clinicians found the addition of Natrox® to standard therapy regimens.

    1. Ease of application (1-5 scale)
    2. Ability to manage the wound effectively (1-5 scale)
    3. Ease of battery management by the patient (scale 1-5)
    4. Conformity to the wound bed (scale 1-5)
    5. Acceptance of the therapy by the patient (scale 1-5)
    6. Patient comfort (scale 1-5)
    7. overall impression (scale 1-5)

  2. Level of pain of the wound [ Time Frame: Twelve (12) weeks from Time 0 ]
    Does pain associated with the wound change over time using a Visual Analogue Scale Each study visit, patient wound pain will be assessed by asking the patient to rank their pain from the wound using a 1-10 scale

  3. Number of Dressing changes [ Time Frame: Twelve (12) weeks from Time 0 ]
    Number of dressing changes that are done on the study wound

  4. Number of adverse events [ Time Frame: Twelve (12) weeks from Time 0 ]
    Number of adverse events, such as infections, that are found associated with the study wound

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03905863

Show Show 21 study locations
Sponsors and Collaborators
Inotec AMD Limited
SerenaGroup, Inc.
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Study Director: Thomas Serena SerenaGroup, Inc.
  Study Documents (Full-Text)

Documents provided by Inotec AMD Limited:
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Responsible Party: Inotec AMD Limited Identifier: NCT03905863    
Other Study ID Numbers: 1
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Inotec AMD Limited:
topical oxygen
topical oxygen treatment
diabetic foot ulcer
non-healing wound
surgical site
wound size
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Wounds and Injuries
Surgical Wound
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases