Treatment of refractory ulcers with Simonkolleite

JRCT ID: jRCTs021210047

Registered date:18/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: refractory skin ulcer
• Date of first enrollment: 18/11/2021
• Target sample size: 10
• Study type: Interventional

Intervention(s)

After thoroughly washing and cleaning the skin ulcer surface of the target patient with physiological saline, 6.4 mg of sterilized simoncolite powder per 1 cm2 of ulcer is evenly sprinkled. After spraying, apply sanitary material according to the amount of exudate as top dressing.
A medical examination is performed every 2-4 days, and the ulcer and surrounding skin are observed. If there is no contamination at the time of observation, do not replace the dressing (or replace only the upper sanitary material), fix it again, and if the wound surface is contaminated, clean the wound and remove Simoncolite powder. Sprinkle the same amount again and coat with new sanitary material. Continue this for 3 weeks.

Outcome(s)

• Primary Outcome: Detection of adverse findings
• Secondary Outcome: Reduction rate of ulcer area and volume

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1. Patients who do not show a healing tendency after 3 weeks or more of existing conservative treatments [ointment treatment, wound dressing, basic fibroblast growth factor (bFGF), continuous negative pressure wound therapy (NPWT) etc.]
2. Patients who explained the purpose of this study in a separate document and obtained written consent

Exclude criteria

1. Patients with ulcer infection
2. Patients with refractory skin ulcers caused by artificial objects
3. Patients with refractory skin ulcers caused by malignant tumors
4. Patients being treated for malignant tumors
5. Pregnant patients
6. Other patients deemed inappropriate by researchers

Related Information

• Primary Sponsor: Norio Fukuda
• Secondary Sponsor: JFE MINERAL Co, LTD.