Clinical trial for sacral pressure sore

A prospective clinical trial for the evaluation of the usefulness and safety of 'BELLALUX Lite' in low grade sacral pressure sore

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0009002

Enrollment

Registered

2023-11-30

Start date

2021-01-11

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

None listed

Interventions

Medical Device : 1.treatment group : Bellalux lite 2.control group : sham

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) grade 2 sacral pressure sore (2) over 13 years

Exclusion criteria

Exclusion criteria: (1) pregnancy (2) history of prior operation for sacral sore (3) recurrence sore (4) osteomyelitis (5) isolation due to general infection (6) cannot change the position (7) use steroid or immunosuppressive drug (8) photosensitive patient (9) Etc.

Design outcomes

Primary

Measure	Time frame
Wound size and degree of reepithelialization.	—

Secondary

Measure	Time frame
immunohistological factors	—

Countries

Korea, Republic of

Contacts

Public ContactKyul Ko

Dongguk University

khmedicare@naver.com+82-70-7552-6031

Outcome results