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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

AOTI Inc. TWO2 topical oxygen therapy equipment

About this trial

This is an interventional treatment trial for Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds focused on measuring chronic wounds, Topical wound oxygen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.
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.

Sites / Locations

2nd Affilated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active arm

Controlled arm

Arm 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.

patients receive standard treatment.

Outcomes

Primary Outcome Measures

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.

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.

Wound healing time

Record of 100% healing wound

Secondary Outcome Measures

Full Information

NCT ID

NCT04168905

First Posted

November 16, 2019

Last Updated

July 13, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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

1. Study Identification

Unique Protocol Identification Number

NCT04168905

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 10, 2020 (Actual)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

chronic wounds, Topical wound oxygen therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active arm

Arm Type

Experimental

Arm Description

Arm Title

Controlled arm

Arm Type

Placebo Comparator

Arm Description

patients receive standard treatment.

Intervention Type

Device

Intervention Name(s)

AOTI Inc. TWO2 topical oxygen therapy equipment

Intervention 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.

Primary Outcome Measure Information:

Title

Wound healing area

Description

The area of wound healing and the appearance of the wound were observed and recorded with each dressing change, and the pictures were collected.

Time Frame

once a week

Title

Wound healing rate

Description

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.

Time Frame

once a week

Title

Wound healing time

Description

Record of 100% healing wound

Time Frame

Under 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Han Chunmao

Phone

13777466111

hanchunmao1@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Han Chunmao

Organizational Affiliation

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

2nd Affilated Hospital, School of Medicine, Zhejiang University, China

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Han Chunmao

Phone

13777466111

hanchunmao1@126.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We will share our study protocol and results without the patients' privacy.

IPD Sharing Time Frame

After our paper's publication.

Citations:

PubMed Identifier

31619393

Citation

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.

Results Reference

result

Learn more about this trial

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

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