Diabetic Foot Ulcer Clinical Trial
Official title:
An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers
NCT number | NCT03863054 |
Other study ID # | 2018/2355 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 17, 2018 |
Est. completion date | May 31, 2021 |
Verified date | September 2021 |
Source | Singapore General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | May 31, 2021 |
Est. primary completion date | March 23, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 21 Years to 90 Years |
Eligibility | Inclusion Criteria: - 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) - 4 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 Exclusion Criteria: - 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 - Diabetic foot ulcer is connected to a sinus wound |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage change in ulcer size | after 12 weeks of NATROX™ therapy, relative to baseline measurement | 12 weeks after NATROX™ fitted | |
Secondary | Absolute Closure Number | Total number of patients with wounds that completely healed at the end of study period | 16 weeks after last patient enrolled | |
Secondary | Wound Closure Rate relative to the 4-week run in period | Number of wounds 100% healed at the end of 4 week run-in | 16 weeks after last patient enrolled | |
Secondary | Number of dressing episodes during the study period | 16 weeks after enrolment | ||
Secondary | Number of infection episodes | 16 weeks after enrolment | ||
Secondary | Diabetic Foot Ulcer Scale | To assess quality of life | Baseline (week 0), Week 4, Week 8, Week 12 and Week 16 post enrolment | |
Secondary | Pain at wound site | Assessed using a visual analogue scale | Baseline (week 0), Week 4, Week 8, Week 12 and Week 16 post enrolment |
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