Clinical trial NCT04168905: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Wounds
Keywords: chronic wounds
Topical wound oxygen therapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Lishui Central Hospital，Lishui Hospital of Zhejiang University
name: Ningbo No.6 Hospita
name: Inner Mongolia People's Hospital
name: Qingdao Hiser Hospital Affiliated to Qingdao University
name: No.1 Hospital of Honghezhou
name: Pingdingshan City Hospital of Traditional Chinese Medicine
name: The department of burns of the first affiliated hospital of SUN YAT-Sen university
name: Hangzhou Enhua Hospital
name: The 1st affiliated hospital of Jinzhou Medicine University
name: Suzhou Municipal Hospital
name: Suzhou Science and Technology City Hospital
name: Shanghai Deji Hospital
name: Wujin people hospital of Changzhou city
name: Affiliated hospital of Xinyang vocational technical institute
name: Sichuan Provincial People's Hospital
name: uncheng Central Hospital of Shanxi Province
name: The Second Affiliated Hospital of Dalian Medical University
name: First Affiliated Hospital of Jinan University
name: First Affiliated Hospital of Wenzhou Medical University
First posted: 2019-11-19
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Wound healing area
timeFrame: once a week
measure: Wound healing rate
timeFrame: once a week
measure: Wound healing time
timeFrame: Under 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affilated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Han Chunmao
role: PRINCIPAL_INVESTIGATOR
References:
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.