Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Wounds

Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04168905
• Other study ID #: 2019-236
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: October 2022

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Han Chunmao
• Phone: 13777466111
• Email: hanchunmao1[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: October 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

?18 years old or older, regardless of gender; ?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; ?Understanding the experimental conditions, Patients are willing to participate in and cooperate with the experimental treatment, and sign the informed consent.

Exclusion Criteria:

1. Edema of lower extremity caused by cardiac insufficiency;

2. patients with venous thrombosis of lower extremity;

3. Diabetics with poor blood glucose control: FBS>=8mmol/L; Blood glucose 2h after meal>=10.0mmol/L; HbA1c >= 9%

4. Participated in similar clinical trials in the last three months; Patients with lower extremity arterial occlusion requiring lower extremity vascular surgery;

5. Patients with wound infection requiring systemic antibiotic therapy;

6. Dry scab or necrotic tissue covered more than 50% of the wound, and was not suitable or refused to accept debridement treatment.

7. Immunodeficiency patients

8. Patients with malignant change of wound or with malignant lesions

9. Patients with wound area greater than 10 cm*10 cm;

10. the wound is deep into sclerotin,articular cavity and body cavity;

11. The wound with sinus tract;

12. patients with serious hepatic dysfunction and malnutrition;

13. Patients with mental or other problems and unable to self-manage equipment

14. Treatment of patients with poor compliance.

15. The researchers think there are other reasons which the patients cannot participate in this clinical trial.

Related Conditions & MeSH terms

• Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds
• Wounds and Injuries

Intervention

Device:
• AOTI Inc. TWO2 topical oxygen therapy equipment
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.

Locations

Country	Name	City	State
China	2nd Affilated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (20)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Affiliated hospital of Xinyang vocational technical institute, First Affiliated Hospital of Jinan University, First Affiliated Hospital of Wenzhou Medical University, Hangzhou Enhua Hospital, Inner Mongolia People's Hospital, Lishui Central Hospital,Lishui Hospital of Zhejiang University, Ningbo No.6 Hospita, No.1 Hospital of Honghezhou, Pingdingshan City Hospital of Traditional Chinese Medicine, Qingdao Hiser Hospital Affiliated to Qingdao University, Shanghai Deji Hospital, Sichuan Provincial People's Hospital, Suzhou Municipal Hospital, Suzhou Science and Technology City Hospital, The 1st affiliated hospital of Jinzhou Medicine University, The department of burns of the first affiliated hospital of SUN YAT-Sen university, The Second Affiliated Hospital of Dalian Medical University, uncheng Central Hospital of Shanxi Province, Wujin people hospital of Changzhou city

Country where clinical trial is conducted

China, 

References & Publications (1)

Frykberg RG, Franks PJ, Edmonds M, Brantley JN, Téot 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Wound healing time	Record of 100% healing wound	Under 12 weeks