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

• Sponsor: Inotec AMD Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03905863
• Collaborator: SerenaGroup, Inc. (Other)
• Enrollment: 145
• Locations: 20
• Arms: 2
• Actual Duration (Months): 16.5
• Patients Per Site: 7.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer; Surgical Wound	Device: Natrox® Oxygen Wound Therapy	N/A

Detailed Description

Patients with diabetic foot ulcers will be enrolled into the trial at multiple wound care centers and hospital research centers across the United States of America. After qualifying per protocol, patients will be randomized to receive standard wound care or standard wound care plus Topical 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 145 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: Jun 4, 2019
• Actual Primary Completion Date: Oct 18, 2020
• Actual Study Completion Date: Oct 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of care arm 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.
Active Comparator: Intervention arm 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; A battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.

Outcome Measures

Primary Outcome Measures

1. 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. [Twelve (12) weeks from Time 0]

   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.

2. Percentage Reduction in Ulcer Area (cm^2). [Twelve (12) weeks from Time 0]

   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.

Secondary Outcome Measures

1. Level of Pain of the Wound [Up to twelve (12) weeks from Time 0]

   Does pain associated with the wound change over time using a Visual Analogue Scale Pain intensity of the reference DFU is to be assessed before any dressing changes or other ulcer manipulations at all screening and treatment visits. Subject will be asked to indicate a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "worst possible pain" on the right side of the number line. The number 0 represent "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain". The subject indicates the level of pain intensity by selecting a number on the line that represents their perception of their current state.

2. Number of Adverse Events [Up to twelve (12) weeks from time 0]

   Number of adverse events, such as infections, that are found associated with the study wound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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:

1. 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.

2. Minor amputation wound sites

1. 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.

2. Study ulcer is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit

3. Subjects' wound score on ISDA tool is Grade 1 or 2.

4. The subject is able and willing to follow the protocol requirements

5. Subject has signed informed consent

6. 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.

7. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).

8. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Hope Podiatry Clinic	Los Angeles	California	United States	90063
2	San Marcus Research Clinic	Miami Lakes	Florida	United States	33014
3	Global Health Research Center Inc	Miami Lakes	Florida	United States	33016
4	MedCare Research	Miami	Florida	United States	33165
5	Barry University Clinical Research	North Miami Beach	Florida	United States	44169
6	Royal Research Corp	Pembroke Pines	Florida	United States	33027
7	Doctors Research Network	South Miami	Florida	United States	33143
8	Pharma Research Associates	Westchester	Florida	United States	33155
9	Wahab Consulting and Research	Las Vegas	Nevada	United States	89148
10	Cleveland Foot and Ankle Clinic	Cleveland	Ohio	United States	44103
11	Tulsa Bone and Joint	Tulsa	Oklahoma	United States	74146
12	The Foot and Ankle Wellness Center of Western Pennsylvania	Ford City	Pennsylvania	United States	16226
13	Antria	Indiana	Pennsylvania	United States	15701
14	ACMH Snyder Institute	Kittanning	Pennsylvania	United States	16201
15	SerenaGroup Research Institute	Pittsburgh	Pennsylvania	United States	15222
16	El Campo Memorial Hospital	El Campo	Texas	United States	77437
17	Allure Health LLC	Friendswood	Texas	United States	77546
18	Pinnacle Foot and Ankle Center	Houston	Texas	United States	77054
19	Mercury Clinical Research	Webster	Texas	United States	77598
20	Clinical Research Management Group	Coto Laurel		Puerto Rico	00780

Sponsors and Collaborators

• Inotec AMD Limited
• SerenaGroup, Inc.

Investigators

• Study Director: Thomas Serena, SerenaGroup, Inc.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Nov 25, 2019

More Information

Publications

None provided.

• Responsible Party: Inotec AMD Limited
• ClinicalTrials.gov Identifier: NCT03905863
• Other Study ID Numbers: 1
• First Posted: Apr 5, 2019
• Last Update Posted: Nov 22, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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; pain; wound size; healing; infection
• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries; Surgical Wound

Study Results

Participant Flow

Recruitment Details

Participants were initially screened and documentation was investigated. If all inclusion criteria were met, and the patient had a documented healing rate of <20% reduction in wound size, the patients were entered into the 2-week run-in period. All patients were allocated to standard of care (SOC). At the baseline visit, if all inclusion and exclusion criteria were still applicable and the wound had not reduced in size by >20%, the patient was then randomized.

Pre-assignment Detail

During run-in period patients either exceeded the percentage of acceptable healing per the protocol or had an adverse event preventing continuation in the trial.

Arm/Group Title	Standard of Care Arm	Intervention Arm
Arm/Group Description	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 standardized 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.	Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design 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 oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device 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.
Period Title: Overall Study
STARTED	64	81
COMPLETED	59	69
NOT COMPLETED	5	12

Baseline Characteristics

Arm/Group Title	Standard of Care Arm	Intervention Arm	Total
Arm/Group Description	Patients in the standard of care arm will receive the standard care for their type of wound from their wound care centre.	Patients in the intervention arm will receive standard of care plus Natrox® Oxygen Wound Therapy as treatment for their wound. 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.	Total of all reporting groups
Overall Participants	64	81	145
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	62.69	64.2	63
Sex: Female, Male (Count of Participants)
Female	11 17.2%	26 32.1%	37 25.5%
Male	53 82.8%	54 66.7%	107 73.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Puerto Rico	8 12.5%	5 6.2%	13 9%
United States	56 87.5%	76 93.8%	132 91%
Current use Tobacco (Count of Participants)
Yes	11 17.2%	11 13.6%	22 15.2%
No	51 79.7%	68 84%	119 82.1%
Not declared	2 3.1%	2 2.5%	4 2.8%
Diabetes duration (years) [Mean (Full Range) ]
Mean (Full Range) [years]	18.33	18.35	18.34
BMI (Kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [Kg/m^2]	31	30.8	30.9

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	Twelve (12) weeks from Time 0

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	Standard of Care Arm	Intervention Arm
Arm/Group Description	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 standardized 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.	Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design 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 oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device 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.
Measure Participants	64	81
Intention to treat-healed	18 28.1%	36 44.4%
Per protocol-healed	18 28.1%	36 44.4%

2. Primary Outcome

Title	Percentage Reduction in Ulcer Area (cm^2).
Description	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.
Time Frame	Twelve (12) weeks from Time 0

Outcome Measure Data

Analysis Population Description

"Intention to treat" as well an "Per protocol" analysis was carried out.

Arm/Group Title	Standard of Care Arm	Intervention Arm
Arm/Group Description	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 standardized 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.	Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design 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 oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device 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.
Measure Participants	64	81
Intention to treat - percentage reduction	41.05 (69.82)	46.38 (100.24)
Per protocol-percentage reduction	40.44 (72.1)	70.18 (45.5)

3. Secondary Outcome

Title	Level of Pain of the Wound
Description	Does pain associated with the wound change over time using a Visual Analogue Scale Pain intensity of the reference DFU is to be assessed before any dressing changes or other ulcer manipulations at all screening and treatment visits. Subject will be asked to indicate a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "worst possible pain" on the right side of the number line. The number 0 represent "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain". The subject indicates the level of pain intensity by selecting a number on the line that represents their perception of their current state.
Time Frame	Up to twelve (12) weeks from Time 0

Outcome Measure Data

Analysis Population Description

VAS scores were taken weekly. On a scale of 0-10, 0 is least pain and 10 is the most pain

Arm/Group Title	Standard of Care Arm	Intervention Arm
Arm/Group Description	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 standardized 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.	Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design 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 oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device 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.
Measure Participants	64	81
Baseline	2.02 (2.57)	1.81 (2.53)
Twelve weeks of final visit if healed during study	0.68 (1.43)	0.95 (1.9)

4. Secondary Outcome

Title	Number of Adverse Events
Description	Number of adverse events, such as infections, that are found associated with the study wound
Time Frame	Up to twelve (12) weeks from time 0

Outcome Measure Data

Analysis Population Description

Adverse reactions were recorded and reported throughout the study as they occurred.

Arm/Group Title	Standard of Care Arm	Intervention Arm
Arm/Group Description	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 standardized 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.	Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design 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 oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device 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.
Measure Participants	64	81
Number of adverse events	32	41
Relationship to the product/unrelated	30	37
Relationship to the product/Unlikely	1	2
Relationship to the product/ Possibly related	1	1
Relationship to the product/ probably related	0	1

Adverse Events

Time Frame	During the12 week intervention period patients were monitored for adverse events.
Adverse Event Reporting Description	Severity of adverse events: Mild, Moderate, Severe, Life Threatening. Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. Action taken: Continued, Interrupted time in study, Discontinued.
Arm/Group Title	Standard of Care Arm		Intervention Arm
Arm/Group Description	Patients in the standard of care arm will receive the standard care for their type of wound from their wound care centre which typically includes a primary and secondary dressing to the wound.		Patients in the intervention arm will receive standard of care plus Natrox® Oxygen Wound Therapy as treatment for their wound. Natrox® Oxygen Wound Therapy: A battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.
All Cause Mortality
	Standard of Care Arm		Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		1/81 (1.2%)
Serious Adverse Events
	Standard of Care Arm		Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/64 (12.5%)		6/81 (7.4%)
Blood and lymphatic system disorders
Bacteremia	1/64 (1.6%)	1	0/81 (0%)	0
General disorders
Pain	1/64 (1.6%)	1	0/81 (0%)	0
Infections and infestations
Gangrene	1/64 (1.6%)	1	1/81 (1.2%)	1
Infection	1/64 (1.6%)	1	2/81 (2.5%)	2
Metabolism and nutrition disorders
Acute hypokalemic	0/64 (0%)	0	1/81 (1.2%)	1
Musculoskeletal and connective tissue disorders
Osteomyelitis	0/64 (0%)	0	1/81 (1.2%)	1
Respiratory, thoracic and mediastinal disorders
Shortness of Breath	3/64 (4.7%)	3	0/81 (0%)	0
Skin and subcutaneous tissue disorders
Cellulitis	1/64 (1.6%)	1	1/81 (1.2%)	1
Other (Not Including Serious) Adverse Events
	Standard of Care Arm		Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/64 (20.3%)		19/81 (23.5%)
Infections and infestations
Wound Infection	2/64 (3.1%)	2	6/81 (7.4%)	6
Infections	3/64 (4.7%)	4	1/81 (1.2%)	1
Injury, poisoning and procedural complications
Falls	2/64 (3.1%)	2	4/81 (4.9%)	7
Skin and subcutaneous tissue disorders
New Wound	7/64 (10.9%)	8	6/81 (7.4%)	6
Maceration	2/64 (3.1%)	4	2/81 (2.5%)	2
Pain	1/64 (1.6%)	1	3/81 (3.7%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.