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

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.

Study Overview

• Status: Recruiting
• Conditions: Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds
• Intervention / Treatment: Device: AOTI Inc. TWO2 topical oxygen therapy equipment

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 Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Han Chunmao; Phone Number: 13777466111; Email: hanchunmao1@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2nd Affilated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Han Chunmao; Phone Number: 13777466111; Email: hanchunmao1@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active arm; 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.	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.
Placebo Comparator: Controlled arm; patients receive standard treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: First Affiliated Hospital of Jinan University; First Affiliated Hospital of Wenzhou Medical University; Sichuan Provincial People's Hospital; Inner Mongolia People's Hospital; The Second Affiliated Hospital of Dalian Medical University; Suzhou Municipal Hospital; Lishui Central Hospital，Lishui Hospital of Zhejiang University; Ningbo No.6 Hospita; 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 Science and Technology City Hospital; Shanghai Deji Hospital; Wujin people hospital of Changzhou city; Affiliated hospital of Xinyang vocational technical institute; uncheng Central Hospital of Shanxi Province
• Investigators: Principal Investigator: Han Chunmao, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: November 16, 2019
• First Submitted That Met QC Criteria: November 16, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: chronic wounds; Topical wound oxygen therapy
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2019-236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We will share our study protocol and results without the patients' privacy.
• IPD Sharing Time Frame: After our paper's publication.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No