Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic WoundsNCT04168905
Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Wounds
A study testing AOTI Inc. TWO2 topical oxygen therapy equipment in people with Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To evaluate the efficacy and clinical satisfaction of topical oxygen therapy (LOT) in chronic wounds (including patients and medical staff), and explore its possible mechanism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds
- What is being tested?
- AOTI Inc. TWO2 topical oxygen therapy equipment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2020to Oct 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ①18 years old or older, regardless of gender;
- ②It was clinically diagnosed as chronic lower limb wound, which was located below the thigh.
- Patients who received mainly etiological treatment, wet dressing change and necessary decompression for more than 2 weeks had no obvious wound healing tendency;
- ③Understanding the experimental conditions, Patients are willing to participate in and cooperate with the experimental treatment, and sign the informed consent.
Who cannot join
- Edema of lower extremity caused by cardiac insufficiency;
- patients with venous thrombosis of lower extremity;
- Diabetics with poor blood glucose control: FBS>=8mmol/L; Blood glucose 2h after meal>=10.0mmol/L; HbA1c >= 9%
- Participated in similar clinical trials in the last three months; Patients with lower extremity arterial occlusion requiring lower extremity vascular surgery;
- Patients with wound infection requiring systemic antibiotic therapy;
- Dry scab or necrotic tissue covered more than 50% of the wound, and was not suitable or refused to accept debridement treatment.
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- Immunodeficiency patients
- Patients with malignant change of wound or with malignant lesions
- Patients with wound area greater than 10 cm*10 cm;
- the wound is deep into sclerotin,articular cavity and body cavity;
- The wound with sinus tract;
- patients with serious hepatic dysfunction and malnutrition;
- Patients with mental or other problems and unable to self-manage equipment
- Treatment of patients with poor compliance.
- The researchers think there are other reasons which the patients cannot participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affilated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
Han Chunmao, 13777466111, hanchunmao1@126.com
About this study
Official title: Multi-Center, Prospective, Randomized,Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Wounds
To evaluate the efficacy and clinical satisfaction of topical oxygen therapy (LOT) in chronic wounds (including patients and medical staff), and explore its possible mechanism.
Read the detailed description
A multi-center open randomized controlled study was conducted. A total of 240 subjects were expected to be accepted. Patients receiving normative wound treatment received cyclic topical oxygen therapy, not excluding the treatment of other diseases.
After signing the informed consent, the patients were randomly divided into the treatment group and the control group. The total treatment time was 12 weeks or the wound healed completely. The enrollment examination included lower limb arteriovenous examination (including B-mode ultrasound, ankle-brachial index), and other related necessary examinations (such as biopsy excluding malignant tumors; blood routine, bacterial culture excluding wound infection; vibration area detection excludes peripheral neuropathy). Relevant examinations and records were made at each time point, including pre-admission and weekly follow-up days. Wound area measurement, image data collection, wound analysis, secretion detection, patient pain score and satisfaction survey, medical staff evaluation were required at each time point. Every patient in the group and the follow-up day should be treated according to the guidance of the doctor according to the type of wound, including wet wound treatment, debridement, decompression, stress treatment and so on.
- Conditions
- Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds
- Being tested
- AOTI Inc. TWO2 topical oxygen therapy equipment
- Keywords
- chronic wounds, Topical wound oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOTI Inc. TWO2 topical oxygen therapy equipmentDevice
Patients will apply themselves oxygen therapy at home for 5 days a week, 90 minutes a day, rest for 2 days, and follow-up once a week. A total of 12 weeks of treatment, or recieving treatment till wound healed.
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Experimental | After receiving standard treatment and AOTI Inc. TWO2 topical oxygen therapy equipment training, patients will apply themselves oxygen therapy at home for 5 days a week, 90 minutes a day, rest for 2 days, and follow-up once a week. A total of 12 weeks of treatment, or recieving treatment till wound healed. Receives: Device: AOTI Inc. TWO2 topical oxygen therapy equipment |
| Controlled arm | Placebo comparator | patients receive standard treatment. Receives: Device: AOTI Inc. TWO2 topical oxygen therapy equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing area
The area of wound healing and the appearance of the wound were observed and recorded with each dressing change, and the pictures were collected.
Measured: once a week
Wound healing rate
Percentage of wound healing, percentage of wound healing at each time point were recorded, and the calculation of wound area was evaluated by measuring tools issued by bidders.
Measured: once a week
Wound healing time
Record of 100% healing wound
Measured: Under 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start10 Jul 2020
- Primary completion1 Jun 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic WoundsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Lishui Central Hospital，Lishui Hospital of Zhejiang University, Ningbo No.6 Hospita, Inner Mongolia People's Hospital, Qingdao Hiser Hospital Affiliated to Qingdao University, No.1 Hospital of Honghezhou, Pingdingshan City Hospital of Traditional Chinese Medicine, The department of burns of the first affiliated hospital of SUN YAT-Sen university, Hangzhou Enhua Hospital, The 1st affiliated hospital of Jinzhou Medicine University, Suzhou Municipal Hospital, Suzhou Science and Technology City Hospital, Shanghai Deji Hospital, Wujin people hospital of Changzhou city, Affiliated hospital of Xinyang vocational technical institute, Sichuan Provincial People's Hospital, uncheng Central Hospital of Shanxi Province, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Jinan University, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Han Chunmao, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168905
- Sponsor's protocol ID
- 2019-236
- Status last verified
- May 2021
- First submitted
- 16 Nov 2019
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share our study protocol and results without the patients' privacy.
Publications
Frykberg RG, Franks PJ, Edmonds M, Brantley JN, Teot L, Wild T, Garoufalis MG, Lee AM, Thompson JA, Reach G, Dove CR, Lachgar K, Grotemeyer D, Renton SC; TWO2 Study Group. A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study. Diabetes Care. 2020 Mar;43(3):616-624. doi: 10.2337/dc19-0476. Epub 2019 Oct 16.
PubMed 31619393
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Prospective, Randomized,Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Wounds
- ClinicalTrials.gov ID
- NCT04168905
- Acronym / sponsor ID
- 2019-236
- Conditions
- Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds
- Keywords
- chronic wounds, Topical wound oxygen therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Lishui Central Hospital，Lishui Hospital of Zhejiang University, Ningbo No.6 Hospita, Inner Mongolia People's Hospital, Qingdao Hiser Hospital Affiliated to Qingdao University, No.1 Hospital of Honghezhou, Pingdingshan City Hospital of Traditional Chinese Medicine, The department of burns of the first affiliated hospital of SUN YAT-Sen university, Hangzhou Enhua Hospital, The 1st affiliated hospital of Jinzhou Medicine University, Suzhou Municipal Hospital, Suzhou Science and Technology City Hospital, Shanghai Deji Hospital, Wujin people hospital of Changzhou city, Affiliated hospital of Xinyang vocational technical institute, Sichuan Provincial People's Hospital, uncheng Central Hospital of Shanxi Province, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Jinan University, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 19 Nov 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.
To evaluate the efficacy and clinical satisfaction of topical oxygen therapy (LOT) in chronic wounds (including patients and medical staff), and explore its possible mechanism.
Detailed description
A multi-center open randomized controlled study was conducted. A total of 240 subjects were expected to be accepted. Patients receiving normative wound treatment received cyclic topical oxygen therapy, not excluding the treatment of other diseases.
After signing the informed consent, the patients were randomly divided into the treatment group and the control group. The total treatment time was 12 weeks or the wound healed completely. The enrollment examination included lower limb arteriovenous examination (including B-mode ultrasound, ankle-brachial index), and other related necessary examinations (such as biopsy excluding malignant tumors; blood routine, bacterial culture excluding wound infection; vibration area detection excludes peripheral neuropathy). Relevant examinations and records were made at each time point, including pre-admission and weekly follow-up days. Wound area measurement, image data collection, wound analysis, secretion detection, patient pain score and satisfaction survey, medical staff evaluation were required at each time point. Every patient in the group and the follow-up day should be treated according to the guidance of the doctor according to the type of wound, including wet wound treatment, debridement, decompression, stress treatment and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Experimental | Device: AOTI Inc. TWO2 topical oxygen therapy equipmentAfter receiving standard treatment and AOTI Inc. TWO2 topical oxygen therapy equipment training, patients will apply themselves oxygen therapy at home for 5 days a week, 90 minutes a day, rest for 2 days, and follow-up once a week. A total of 12 weeks of treatment, or recieving treatment till wound healed. |
| Controlled arm | Placebo comparator | Device: AOTI Inc. TWO2 topical oxygen therapy equipmentpatients receive standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ①18 years old or older, regardless of gender;
- ②It was clinically diagnosed as chronic lower limb wound, which was located below the thigh.
- Patients who received mainly etiological treatment, wet dressing change and necessary decompression for more than 2 weeks had no obvious wound healing tendency;
- ③Understanding the experimental conditions, Patients are willing to participate in and cooperate with the experimental treatment, and sign the informed consent.
Key exclusion criteria (15 listed)
- Edema of lower extremity caused by cardiac insufficiency;
- patients with venous thrombosis of lower extremity;
- Diabetics with poor blood glucose control: FBS>=8mmol/L; Blood glucose 2h after meal>=10.0mmol/L; HbA1c >= 9%
- Participated in similar clinical trials in the last three months; Patients with lower extremity arterial occlusion requiring lower extremity vascular surgery;
- Patients with wound infection requiring systemic antibiotic therapy;
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 |
|---|---|---|
| AOTI Inc. TWO2 topical oxygen therapy equipmentPatients will apply themselves oxygen therapy at home for 5 days a week, 90 minutes a day, rest for 2 days, and follow-up once a week. A total of 12 weeks of treatment, or recieving treatment till wound healed. | Device | Active arm, Controlled arm |
Primary outcome
Wound healing area
Time frame: once a week
The area of wound healing and the appearance of the wound were observed and recorded with each dressing change, and the pictures were collected.
Wound healing rate
Time frame: once a week
Percentage of wound healing, percentage of wound healing at each time point were recorded, and the calculation of wound area was evaluated by measuring tools issued by bidders.
Wound healing time
Time frame: Under 12 weeks
Record of 100% healing wound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Results publication: PubMed 31619393Frykberg RG, Franks PJ, Edmonds M, Brantley JN, Teot L, Wild T, Garoufalis MG, Lee AM, Thompson JA, Reach G, Dove CR, Lachgar K, Grotemeyer D, Renton SC; TWO2 Study Group. A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study. Diabetes Care. 2020 Mar;43(3):616-624. doi: 10.2337/dc19-0476. Epub 2019 Oct 16.
- Individual participant dataSharing planned: Yes. We will share our study protocol and results without the patients' privacy.
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.
Han Chunmao principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOTI Inc. TWO2 topical oxygen therapy equipment in people with Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 19 Jul 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Chunmao (13777466111, hanchunmao1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing area (time frame: once a week). The study lists 3 primary outcomes in all. 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 NCT04168905, which also lists 1 linked publication.
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 19 Jul 2021.