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

Multi-Center, Prospective, Randomized,Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Wounds

Sponsors

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Brief 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.

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.

Overall Status Recruiting
Start Date December 2019
Completion Date October 2021
Primary Completion Date June 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Wound healing area once a week
Wound healing rate once a week
Wound healing time Under 12 weeks
Enrollment 192
Condition
Intervention

Intervention Type: Device

Intervention Name: AOTI Inc. TWO2 topical oxygen therapy equipment

Description: 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.

Eligibility

Criteria:

Inclusion Criteria:

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.

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Han Chunmao Principal Investigator 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Overall Contact

Last Name: Han Chunmao

Phone: 13777466111

Email: [email protected]

Location
Facility: Status: Contact: 2nd Affilated Hospital, School of Medicine, Zhejiang University, China Han Chunmao 13777466111 [email protected]
Location Countries

China

Verification Date

October 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Active arm

Type: Experimental

Description: 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.

Label: Controlled arm

Type: Placebo Comparator

Description: patients receive standard treatment.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov