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A randomized, controlled and single-center trial on use of photocurable wound sealing hydrogel for chronic wounds

A randomized, controlled and single-center trial on use of photocurable wound sealing hydrogel for chronic wounds

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043569
Enrollment
Unknown
Registered
2021-02-21
Start date
2021-02-20
Completion date
Unknown
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic wounds

Interventions

photocurable wound sealing hydrogel group:photocurable wound sealing hydrogel
conventional standard therapy group:Vaseline gauze

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years old; 2. The patients diagnosed as chronic wounds could not recover more than 1 month after standard treatment, or healing time should be more than 1 month; 3. Vital signs were stable, no obvious local or systemic infection symptoms, and no serious organ diseases; 4. Blood glucose was controlled well, with fasting blood glucose < 7.0mmol/L and 2 hours postprandial blood glucose < 11.1 mmol/L; 5. Patients with ankle brachial index (ABI) between 0.7 and 1.3; 6. Voluntary participation and sign on the informed consent.

Exclusion criteria

Exclusion criteria: 1. Existing diseases can seriously affect wound healing (severe anemia (Hb < 60g/L), hypoproteinemia (ALB < 25g/L), malignancy, autoimmune connective tissue disease, etc.); 2. Radiation ulcers and malignant lesions in the ulcers; 3. Currently receiving radiotherapy or chemotherapy or taking hormones, immunosuppressant; 4. Patients with serious and life-threatening diseases, or with heart, liver, kidney, lung dysfunction; 5. Patients who are allergic or hypersensitive to penicillin 6. HIV1, HIV2, HBV, HCV, HTLV1 or syphilis positive; 7. Serious mental illness; 8. Pregnancy and breast-feeding women, or women with the intention to pregnancy; 9. Patients with stroke or limbs autonomic dysfunction; 10. Participated in other clinical trials last 3 months; 11. Other cases that researchers believe not suitable for the participants of the trial.

Design outcomes

Primary

MeasureTime frame
wound healing rate;

Secondary

MeasureTime frame
hemostasis;pain visual analog scales;

Countries

China

Contacts

Public ContactZhaofan Xia

Shanghai Changhai Hospital

xiazhaofan_smmu@163.com+86 21 81873213

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026