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| Name | Class |
|---|---|
| Lishui Central Hospital,Lishui Hospital of Zhejiang University | UNKNOWN |
| Ningbo No.6 Hospita | UNKNOWN |
| Inner Mongolia People's Hospital | OTHER |
| Qingdao Hiser Hospital Affiliated to Qingdao University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Controlled arm | Placebo Comparator | patients receive standard treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AOTI Inc. TWO2 topical oxygen therapy equipment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | once a week |
| Wound healing time | Record of 100% healing wound | Under 12 weeks |
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Inclusion Criteria:
â‘ 18 years old or older, regardless of gender;
â‘¡It 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;
â‘¢Understanding the experimental conditions, Patients are willing to participate in and cooperate with the experimental treatment, and sign the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han Chunmao | Contact | 13777466111 | hanchunmao1@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Han Chunmao | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affilated Hospital, School of Medicine, Zhejiang University, China | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31619393 | Result | 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. |
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We will share our study protocol and results without the patients' privacy.
After our paper's publication.
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| UNKNOWN |
| No.1 Hospital of Honghezhou | UNKNOWN |
| Pingdingshan City Hospital of Traditional Chinese Medicine | UNKNOWN |
| The department of burns of the first affiliated hospital of SUN YAT-Sen university | UNKNOWN |
| Hangzhou Enhua Hospital | UNKNOWN |
| The 1st affiliated hospital of Jinzhou Medicine University | UNKNOWN |
| Suzhou Municipal Hospital | OTHER |
| Suzhou Science and Technology City Hospital | UNKNOWN |
| Shanghai Deji Hospital | UNKNOWN |
| Wujin people hospital of Changzhou city | UNKNOWN |
| Affiliated hospital of Xinyang vocational technical institute | UNKNOWN |
| Sichuan Provincial People's Hospital | OTHER |
| uncheng Central Hospital of Shanxi Province | UNKNOWN |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| First Affiliated Hospital of Jinan University | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
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