None listed
Conditions
Interventions
Medical Device : Beta Foam is applied to infected wounds to prevent absorption of exudate, bleeding or loss of body fluids and contamination. It contains povidone-iodine disinfectant and has antibacte
Sponsors
Catholic Kwandong University International St.Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female patients aged 18 years or older 2) Patients consented to clinical plan and clinical follow-up, and who gave consent in written form approved by the Institutional Review Board 3) Patients with diabetic foot ulcers who have all of the following - Target ulcer present below the ankle (If two or more ulcer lesions exist, the largest ulcer is considered the target ulcer. If there are ulcers of the same size, the ulcer with a higher Wagner grade is considered the target ulcer.) - Wagner Grade I or II - Patients with ulcers larger than 1*1cm2 (length*width) after debridement
Exclusion criteria
Exclusion criteria: 1) Patients consented to clinical plan and clinical follow-up, and did not consent to the written approval of the Institutional Review Board 2) Pregnant or breast feeding women 3) Patients with hypersensitivity to povidone-iodine, a medical device for clinical trials 4) Hyperthyroidism patients or other thyroid dysfunction patients(nodular goiter, endemic goiter, Hashimoto's thyroiditis, etc.) or those receiving radioactive iodine treatment 5) Those who are participating in other interventional studies at the time of registration 6) Those with comorbidities that may affect wound healing; Malignant tumor, vasculitis, connective tissue disease, etc. 7) Patients with immunosuppression(chemotherapy, End-stage renal disease undergoing dialysis or requiring dialysis, patients with a history of previous renal transplantation or receiving specific immunosuppressants, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Size of the ulcer | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analog scale (VAS) for pain, Foot function index (FFI) | — |
Countries
Korea, Republic of
Contacts
Public ContactDong Woo Shim
Catholic Kwandong University International St.Mary's Hospital
Outcome results
None listed