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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Lishui Central Hospital，Lishui Hospital of Zhejiang University

  collaborator UNKNOWN

• Ningbo No.6 Hospita

  collaborator UNKNOWN

• Inner Mongolia People's Hospital

  collaborator OTHER

• Qingdao Hiser Hospital Affiliated to Qingdao University

  collaborator UNKNOWN

• No.1 Hospital of Honghezhou

  collaborator UNKNOWN

• Pingdingshan City Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• The department of burns of the first affiliated hospital of SUN YAT-Sen university

  collaborator UNKNOWN

• Hangzhou Enhua Hospital

  collaborator UNKNOWN

• The 1st affiliated hospital of Jinzhou Medicine University

  collaborator UNKNOWN

• Suzhou Municipal Hospital

  collaborator OTHER

• Suzhou Science and Technology City Hospital

  collaborator UNKNOWN

• Shanghai Deji Hospital

  collaborator UNKNOWN

• Wujin people hospital of Changzhou city

  collaborator UNKNOWN

• Affiliated hospital of Xinyang vocational technical institute

  collaborator UNKNOWN

• Sichuan Provincial People's Hospital

  collaborator OTHER

• uncheng Central Hospital of Shanxi Province

  collaborator UNKNOWN

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Han Chunmao · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-10

Primary Completion

2022-06-01

Completion

2022-10-31

Countries

• China

Study Locations