Pilot study to evaluate the efficacy and safety of MegaNuovo in Pressure sore patients : single center, comparative, investigator-initiated pilot study
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0006745
- Lead Sponsor
- Yonsei University, Wonju Severance Christian Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
? Patients aged 19 to less than 90 years of age
? Patients with stage 2~4 pressure ulcers
? Patients who have fully explained the purpose and contents of the test before taking the test and voluntarily signed the written consent (a legal representative can represent him if necessary)
? Patients who can follow-up during the test period
? HbA1c=12%
? Patients with evidence of active infection including osteomyelitis or cellulitis
? Patients who want surgical treatment
? Pregnant and lactating women (urine hCG test)
? Patients with psychiatric problems
? Patients with infectious diseases, systemic autoimmune diseases (rheumatic diseases, etc.), blood clotting disorders (diagnosed by medical staff through questionnaire and physical examination)
? In case it is judged difficult to conduct clinical trials by the principal investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of change in the size of the ulcer at 4 weeks by group
- Secondary Outcome Measures
Name Time Method The stage of the ulcer ;rate of infection;laboratory test;Proportion of patients with complete healing;The rate of change in the size of the ulcer