An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers

NCT03863054 | Completed

• 1 other identifier: 2018/2355
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of NATROX™ Topical Oxygen Wound Therapy for subjects with non-healing foot ulceration. Subjects will be treated with standard care for 4 weeks. If the wound is not reduced by more than 40%, NATROX™ will be applied for the next 12 weeks. Throughout the study period, wound measurements will be taken to measure wound reduction.

Conditions

Diabetic Foot Ulcer; Non-healing Wound

Keywords

Topical Oxygen; Wound Management

Outcome Measures

Primary Outcomes (1)

• Percentage change in ulcer size

  after 12 weeks of NATROX™ therapy, relative to baseline measurement

  12 weeks after NATROX™ fitted

Secondary Outcomes (6)

• Absolute Closure Number

  16 weeks after last patient enrolled

• Wound Closure Rate relative to the 4-week run in period

  16 weeks after last patient enrolled

• Number of dressing episodes during the study period

  16 weeks after enrolment

• Number of infection episodes

  16 weeks after enrolment

• Diabetic Foot Ulcer Scale

  Baseline (week 0), Week 4, Week 8, Week 12 and Week 16 post enrolment

Study Arms (2)

>40% wound area reduction after 1 month

Subjects to continue with standard practice for the next 12 weeks, or until the wound has completely healed.

<40% wound area reduction after 1 month

Subjects to be fitted with NATROX™ after 1 month, over a period of 12 weeks or until the wound has completely healed.

Device: NATROX™ Topical Oxygen Therapy System

Interventions

NATROX™ Topical Oxygen Therapy System DEVICE

A small battery-powered electrochemical "oxygen generator" to concentrate atmospheric oxygen and feed to wound site through a dressing-like "oxygen distribution system"

<40% wound area reduction after 1 month

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with non-healing Diabetic Foot Ulcers that has been persistent for more than 3 months, or less than 50% healing observed within 1 month for amputation sites.

You may qualify if:

• A diabetic foot ulcer greater than 12 weeks and less than 18 months in duration
• Minor amputation sites \<50% healed in 4 weeks (the use of negative pressure wound therapy to optimize the wound bed is allowable)
• weeks of standard of care at the hospital based diabetic foot clinic or in a specialist community diabetic podiatry clinic prior to entry into the open registry
• No planned revascularization (endovascular or open surgery) within 4 weeks following revascularization being performed)
• Ongoing active chemical or sharp wound debridement prior to and during the application of NATROX™
• No limit on level of ischemia, either high or low. The extent of arterial disease will be documented by angiogram or duplex ultrasound and toe blood pressure
• The subject is 21 years of age or older
• The subject is willing to complete \>75% of follow-up evaluations required by the study protocol
• The subject is able to abstain from any other clinical trial for the duration of the study
• The study is able to read and understand instructions and give voluntary written informed consent
• The subject is able and willing to follow the protocol requirements

You may not qualify if:

• Inability to comply with the dressing regime or manage the NATROX™ device
• Disseminated malignancy
• Subjects with a \>1 year life expectancy
• Subjects with an ulcer which is \<0.5cm2 or \>50cm2
• Subjects who is dialysis dependent for less than 1 year (i.e. subject is eligible for study if has CKD/ESRF and is on dialysis for \>1year)
• The subject has an invasive soft tissue infection at the time of baseline assessment, requiring oral or intravenous antibiotic therapy.
• Exposed bone without soft tissue or granulation tissue across the surface
• Acute osteomyelitis (stable, chronic osteomyelitis is allowable, including those maintained on oral antibiotics, as long as there is no planned intervention)
• Pregnant/lactating females (self-reported or tested, as per institutional requirements)
• Glycated haemoglobin HbA1C of \>12mmol mol-1
• Subject who have evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) under active treatment
• The subject is unable to follow the protocol
• The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
• The patient is a vulnerable or protected adult
• The patient is unable to provide informed consent

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (14)

• Blackman E, Moore C, Hyatt J, Railton R, Frye C. Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: a prospective controlled study. Ostomy Wound Manage. 2010 Jun;56(6):24-31.

  PMID: 20567051 BACKGROUND

• Driver VR, Yao M, Kantarci A, Gu G, Park N, Hasturk H. A prospective, randomized clinical study evaluating the effect of transdermal continuous oxygen therapy on biological processes and foot ulcer healing in persons with diabetes mellitus. Ostomy Wound Manage. 2013 Nov;59(11):19-26.

  PMID: 24201169 BACKGROUND

• Gordillo GM, Sen CK. Evidence-based recommendations for the use of topical oxygen therapy in the treatment of lower extremity wounds. Int J Low Extrem Wounds. 2009 Jun;8(2):105-11. doi: 10.1177/1534734609335149.

  PMID: 19443899 BACKGROUND

• Hirsh F, Berlin SJ, Holtz A. Transdermal oxygen delivery to diabetic wounds: a report of 6 cases. Adv Skin Wound Care. 2009 Jan;22(1):20-4. doi: 10.1097/01.ASW.0000343722.22943.40.

  PMID: 19096280 BACKGROUND

• Gordillo GM, Roy S, Khanna S, Schlanger R, Khandelwal S, Phillips G, Sen CK. Topical oxygen therapy induces vascular endothelial growth factor expression and improves closure of clinically presented chronic wounds. Clin Exp Pharmacol Physiol. 2008 Aug;35(8):957-64. doi: 10.1111/j.1440-1681.2008.04934.x. Epub 2008 Apr 21.

  PMID: 18430064 BACKGROUND

• Driver VR, Reyzelman A, Kawalec J, French M. A Prospective, Randomized, Blinded, Controlled Trial Comparing Transdermal Continuous Oxygen Delivery to Moist Wound Therapy for the Treatment of Diabetic Foot Ulcers. Ostomy Wound Manage. 2017 Apr;63(4):12-28.

  PMID: 28448266 BACKGROUND

• Tawfick WA, Sultan S. Technical and clinical outcome of topical wound oxygen in comparison to conventional compression dressings in the management of refractory nonhealing venous ulcers. Vasc Endovascular Surg. 2013 Jan;47(1):30-7. doi: 10.1177/1538574412467684. Epub 2012 Dec 5.

  PMID: 23223182 BACKGROUND

• Niederauer MQ, Michalek JE, Armstrong DG. A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen Therapy to Sham Therapy in the Treatment of Diabetic Foot Ulcers. J Diabetes Sci Technol. 2017 Sep;11(5):883-891. doi: 10.1177/1932296817695574. Epub 2017 Feb 15.

  PMID: 28654304 BACKGROUND

• Tawfick W, Sultan S. Does topical wound oxygen (TWO2) offer an improved outcome over conventional compression dressings (CCD) in the management of refractory venous ulcers (RVU)? A parallel observational comparative study. Eur J Vasc Endovasc Surg. 2009 Jul;38(1):125-32. doi: 10.1016/j.ejvs.2009.03.027. Epub 2009 May 22.

  PMID: 19464933 BACKGROUND

• Woo KY, Coutts PM, Sibbald RG. Continuous topical oxygen for the treatment of chronic wounds: a pilot study. Adv Skin Wound Care. 2012 Dec;25(12):543-7. doi: 10.1097/01.ASW.0000423439.62789.90.

  PMID: 23151764 BACKGROUND

• Yu J, Lu S, McLaren AM, Perry JA, Cross KM. Topical oxygen therapy results in complete wound healing in diabetic foot ulcers. Wound Repair Regen. 2016 Nov;24(6):1066-1072. doi: 10.1111/wrr.12490. Epub 2016 Nov 2.

  PMID: 27733020 BACKGROUND

• Hayes PD, Alzuhir N, Curran G, Loftus IM. Topical oxygen therapy promotes the healing of chronic diabetic foot ulcers: a pilot study. J Wound Care. 2017 Nov 2;26(11):652-660. doi: 10.12968/jowc.2017.26.11.652.

  PMID: 29131746 BACKGROUND

• Mani R. Topical oxygen therapy for chronic wounds: a report on the potential of NATROX™ - a new device for delivering enriched oxygen to chronic wounds. Journal of Wound Technology 9:28-30, 2010

  BACKGROUND

• Tang TY, Mak MYQ, Yap CJQ, Boey JEC, Chan SL, Soon SXY, Ishak IAB, Lee RWL, Soh XJ, Goh WX. An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (Natrox) on the Rates of Healing of Chronic DiAbetic Foot Ulcers (OTONAL Trial). Int J Low Extrem Wounds. 2024 Jun;23(2):326-337. doi: 10.1177/15347346211053694. Epub 2021 Nov 6.

  PMID: 34747267 DERIVED

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Tang Tjun Yip

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 5, 2019
• Study Start: August 17, 2018
• Primary Completion: March 23, 2021
• Study Completion: May 31, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)