NCT04168905

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

July 10, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 19, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

November 16, 2019

Last Update Submit

July 13, 2021

Conditions

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

Keywords

chronic woundsTopical wound oxygen therapy

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Active arm

EXPERIMENTAL

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

Controlled arm

PLACEBO COMPARATOR

patients receive standard treatment.

Device: AOTI Inc. TWO2 topical oxygen therapy equipment

Interventions

AOTI Inc. TWO2 topical oxygen therapy equipmentDEVICE

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.

Active armControlled arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31619393RESULT

Study Officials

  • Han Chunmao

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Chunmao

CONTACT

13777466111hanchunmao1@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2019

First Posted

November 19, 2019

Study Start

July 10, 2020

Primary Completion

June 1, 2022

Study Completion

October 1, 2022

Last Updated

July 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After our paper's publication.

Locations

CN(1)