Diabetic Foot UlcerNCT03863054
An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers
An observational study of Diabetic Foot Ulcer and Non-healing Wound, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcer, Non-healing Wound
- What is being tested?
- NATROX™ Topical Oxygen Therapy System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 17 Aug 2018to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Diabetes and its attendant complications are increasing year on year. A number of macro- and micro-circulatory changes occur as a result of long standing or poorly controlled diabetes. These, often in association with either loss of lower limb sensation, or mechanical changes in the foot architecture, can lead to the formation of foot ulcers. These can be hard to heal because of the changes in the diabetic foot described above, as well as an increased incidence of infection in this population. Invasive or ascending infection through these breaks in the skin can lead to tissue loss, which may range from a single toe to major amputation below or above the knee. Major limb amputation has a profound effect on patient's quality of life, as well as a significant economic impact on the health and social care budget. Caring for diabetic foot ulcers, and the complications of this, have a cost of around S$1.2 billion per annum, which has become a focus of public health concern in Singapore recently.
The concept of increasing the oxygen concentration in healing wounds developed originally with hyperbaric oxygen therapy, and from the fact that oxygen is one of the most essential elements used during cellular metabolism. Poor tissue oxygenation, as is often seen in diabetic foot ulcers, is a significant impediment to cellular activity, and is therefore very likely to impair wound healing.
The NATROX™ topical oxygen therapy system developed by Inotec AMD Limited employs a small battery-powered electrochemical "oxygen generator" to concentrate atmospheric oxygen and feed the pure, moist, oxygen at a rate of around 13ml/hour through a fine, soft, tube to a dressing-like "oxygen distribution system" that is placed over the wound and is held in place by a conventional dressing. The oxygen generator is worn in a holster on the waist or above the calf, or is placed in a trouser pocket, thus enabling the patient to enjoy normal mobility (hence "ambulatory") while receiving continuous treatment.
The very significant costs of treatment of diabetic foot ulcers and the impact of amputations on quality of life and life expectancy, suggest that Natrox™ treatment is likely to be cost effective, a conclusion that was evident from the brief independent health economics study linked to the project. To date, no Asian study looking at whether the device is efficacious in a multi-racial population like Singapore. The vessels in Asians are generally smaller and the micro circulation is generally more diseased than our Caucasian counterparts because of the higher incidence of diabetes. This technology could be ideal for such patients and improve our limb salvage rates. After revascularization and control of infection, there is little alternative if the wound does not heal apart from further wound debridement or major amputation. This study may show us which Diabetic Foot Ulcers or wounds are likely to respond to topical oxygen and what effect it has on the patient per se in terms of pain relief and improvement of quality of life.
- Conditions
- Diabetic Foot Ulcer, Non-healing Wound
- Being tested
- NATROX™ Topical Oxygen Therapy System
- Keywords
- Topical Oxygen, Wound Management
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NATROX™ Topical Oxygen Therapy SystemDevice
A small battery-powered electrochemical "oxygen generator" to concentrate atmospheric oxygen and feed to wound site through a dressing-like "oxygen distribution system"
| Study group | Role | What they receive |
|---|---|---|
| >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. Receives: Device: NATROX™ Topical Oxygen Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in ulcer size
after 12 weeks of NATROX™ therapy, relative to baseline measurement
Measured: 12 weeks after NATROX™ fitted
Secondary outcomes (6)
Absolute Closure Number
Total number of patients with wounds that completely healed at the end of study period
Measured: 16 weeks after last patient enrolled
Wound Closure Rate relative to the 4-week run in period
Number of wounds 100% healed at the end of 4 week run-in
Measured: 16 weeks after last patient enrolled
Number of dressing episodes during the study period
Measured: 16 weeks after enrolment
Number of infection episodes
Measured: 16 weeks after enrolment
Diabetic Foot Ulcer Scale
To assess quality of life
Measured: Baseline (week 0), Week 4, Week 8, Week 12 and Week 16 post enrolment
Pain at wound site
Assessed using a visual analogue scale
Measured: Baseline (week 0), Week 4, Week 8, Week 12 and Week 16 post enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start17 Aug 2018
- Primary completion23 Mar 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tang Tjun Yip, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863054
- Sponsor's protocol ID
- 2018/2355
- Status last verified
- Sep 2021
- First submitted
- 4 Mar 2019
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20567051Driver 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.
PubMed 24201169Gordillo 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.
PubMed 19443899Hirsh 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.
PubMed 19096280Gordillo 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.
PubMed 18430064Driver 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.
PubMed 28448266Tawfick 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.
PubMed 23223182Niederauer 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.
PubMed 28654304Tawfick 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.
PubMed 19464933Woo 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.
PubMed 23151764Yu 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.
PubMed 27733020Hayes 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.
PubMed 29131746Mani 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
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.
PubMed 34747267
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03863054
- Acronym / sponsor ID
- 2018/2355
- Conditions
- Diabetic Foot Ulcer, Non-healing Wound
- Keywords
- Topical Oxygen, Wound Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetes and its attendant complications are increasing year on year. A number of macro- and micro-circulatory changes occur as a result of long standing or poorly controlled diabetes. These, often in association with either loss of lower limb sensation, or mechanical changes in the foot architecture, can lead to the formation of foot ulcers. These can be hard to heal because of the changes in the diabetic foot described above, as well as an increased incidence of infection in this population. Invasive or ascending infection through these breaks in the skin can lead to tissue loss, which may range from a single toe to major amputation below or above the knee. Major limb amputation has a profound effect on patient's quality of life, as well as a significant economic impact on the health and social care budget. Caring for diabetic foot ulcers, and the complications of this, have a cost of around S$1.2 billion per annum, which has become a focus of public health concern in Singapore recently.
The concept of increasing the oxygen concentration in healing wounds developed originally with hyperbaric oxygen therapy, and from the fact that oxygen is one of the most essential elements used during cellular metabolism. Poor tissue oxygenation, as is often seen in diabetic foot ulcers, is a significant impediment to cellular activity, and is therefore very likely to impair wound healing.
The NATROX™ topical oxygen therapy system developed by Inotec AMD Limited employs a small battery-powered electrochemical "oxygen generator" to concentrate atmospheric oxygen and feed the pure, moist, oxygen at a rate of around 13ml/hour through a fine, soft, tube to a dressing-like "oxygen distribution system" that is placed over the wound and is held in place by a conventional dressing. The oxygen generator is worn in a holster on the waist or above the calf, or is placed in a trouser pocket, thus enabling the patient to enjoy normal mobility (hence "ambulatory") while receiving continuous treatment.
The very significant costs of treatment of diabetic foot ulcers and the impact of amputations on quality of life and life expectancy, suggest that Natrox™ treatment is likely to be cost effective, a conclusion that was evident from the brief independent health economics study linked to the project. To date, no Asian study looking at whether the device is efficacious in a multi-racial population like Singapore. The vessels in Asians are generally smaller and the micro circulation is generally more diseased than our Caucasian counterparts because of the higher incidence of diabetes. This technology could be ideal for such patients and improve our limb salvage rates. After revascularization and control of infection, there is little alternative if the wound does not heal apart from further wound debridement or major amputation. This study may show us which Diabetic Foot Ulcers or wounds are likely to respond to topical oxygen and what effect it has on the patient per se in terms of pain relief and improvement of quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| >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 | – | Device: NATROX™ Topical Oxygen Therapy SystemSubjects to be fitted with NATROX™ after 1 month, over a period of 12 weeks or until the wound has completely healed. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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™
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NATROX™ Topical Oxygen Therapy SystemA small battery-powered electrochemical "oxygen generator" to concentrate atmospheric oxygen and feed to wound site through a dressing-like "oxygen distribution system" | Device | <40% wound area reduction after 1 month |
Primary outcome
Percentage change in ulcer size
Time frame: 12 weeks after NATROX™ fitted
after 12 weeks of NATROX™ therapy, relative to baseline measurement
6 secondary outcomes
Absolute Closure Number
Time frame: 16 weeks after last patient enrolled
Wound Closure Rate relative to the 4-week run in period
Time frame: 16 weeks after last patient enrolled
Number of dressing episodes during the study period
Time frame: 16 weeks after enrolment
Number of infection episodes
Time frame: 16 weeks after enrolment
Diabetic Foot Ulcer Scale
Time frame: Baseline (week 0), Week 4, Week 8, Week 12 and Week 16 post enrolment
Pain at wound site
Time frame: Baseline (week 0), Week 4, Week 8, Week 12 and Week 16 post enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 20567051Blackman 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.
- Background: PubMed 24201169Driver 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.
- Background: PubMed 19443899Gordillo 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.
- Background: PubMed 19096280Hirsh 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.
- Background: PubMed 18430064Gordillo 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.
- Background: PubMed 28448266Driver 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.
- Background: PubMed 23223182Tawfick 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.
- Background: PubMed 28654304Niederauer 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.
- Background: PubMed 19464933Tawfick 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.
- Background: PubMed 23151764Woo 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.
- Background: PubMed 27733020Yu 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.
- Background: PubMed 29131746Hayes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tang Tjun Yip principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Non-healing Wound, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in ulcer size (time frame: 12 weeks after NATROX™ fitted). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863054, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.