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Clinical study for efficacy and safety of bone marrow derived cell concentrate and allogenic dermal matrix complex therapy in diabetic foot ulcer

Clinical study for efficacy and safety of bone marrow derived cell concentrate and allogenic dermal matrix complex therapy in diabetic foot ulcer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009122
Enrollment
58
Registered
2024-01-19
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell, Procedure/Surgery : After measuring the patient s wound size at the initial visit, the amount of bone marrow collected is 30cc if less than 10cm2, 60cc if less than 20cm

Sponsors

Soon Chun Hyang University Hospital Bucheon
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Patients with intractable foot ulcers due to diabetes measuring between 2 x 2 cm² and less than 12 x 12 cm² ? Patients with diabetic foot ulcers that do not heal for 3 weeks despite conventional conventional wound treatment ? Patients with diabetic foot ulcers who have ABI <0.7 or who have undergone percutaneous angioplasty in cases where the wound exposes bone or tendon accompanied by infection. ? Adults over 19 years old, under 70 years old ? Those who signed the consent form after receiving an explanation of the purpose, methods, and effects of this study

Exclusion criteria

Exclusion criteria: ? Those who have been diagnosed with a malignant blood disease such as lymphoma or leukemia and have not experienced remission ? People with severe anemia and other blood diseases ? Those who have a history of solid cancer or have been diagnosed with solid cancer and are currently undergoing chemotherapy ? Those who have undergone major surgical operations, organ biopsies, or significant trauma at the discretion of the researcher within 3 months prior to registration ? Those with active infection ? Those who are receiving or are scheduled to receive drugs that, as determined by the researcher, may affect the results ? Persons who are unable to comply with the research plan and follow-up observations ? Those who participated in another clinical trial within 30 days before registration ? A person who is deemed inappropriate by the researcher to participate in this study. ? Those currently taking steroids or immunosuppressants ? Persons who did not sign the written consent form for this clinical study

Design outcomes

Primary

MeasureTime frame
Black eschar, Eczema/dermatitis, Depth, Scarring, Color of wound bed, Oedema/Swelling, Resurfacing epithelium, and Exudate amount

Secondary

MeasureTime frame
Degree of pain change: NRS (Numeric rating scale)

Countries

Korea, Republic of

Contacts

Public ContactYeonsu Choi

Soon Chun Hyang University Hospital Bucheon

118629@schmc.ac.kr+82-32-621-5319

Outcome results

None listed

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