Non-healing Foot Ulcer
Conditions
Interventions
For patients with chronic ulcer on the sole of the foot that can not be healed with standard therapy for over 4 weeks, to immobilize with TCC which spread the pressure on the sole for the avoidance of
Sponsors
Saga University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Chronic ulcers in the plantar area. 2.Ambulatory patient 3.Debridement has been done in the presence of necrotic tissue and/or infection. 4.Ulcers with a small or moderate amount of discharge. 5.To be performed with the principle of consent, given in writing, by the person himself. However, if the document of consent from the person cannot be obtained for any reason, a legal representative (legal representative of the person being treated) agrees to allow the procedure(s)
Exclusion criteria
Exclusion criteria: 1.Presence of ulcers in both the forefoot and the heel. 2.Local infection on the ulcer area and/or systemic infection. 3.In the case of bone exposure or radiographic signs of myelitis.findings. 4.Negative arterial Doppler examination for the dorsalis pedis artery and/or the posterior tibial artery due to critical limb ischemia. 5.Plantar ulcers exist bilaterally or the contralateral foot has been amputated. 6.Malignant tumor exists in the wound bed or its surroundings. 7.Uncontrollable bleeding from the wound. 8.Deep venous thrombosis, varicose veins, or lymphedema. 9.Radiation therapy, chemotherapy, VEGF inhibitor, or administration of steroids. 10.Poor general status, under-nutrition, coagulopathy, or connective tissue disease. 11.A pregnant or breast-feeding woman or a child. 12.Patients who cannot come to our hospital. 13.Patients judged to be inappropriate for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer Healing (at 12 weeks) Time required for complete healing | — |
Secondary
| Measure | Time frame |
|---|---|
| The presence or absence of ulcer occurrence of other sites up to 12 weeks after the operation. Presence or absence of complications. Period up to good granulation Ulcerogenic at other sites. Occurrence of other complications. TCC wearing period. Total cost of care for wound treatment. Time-dependent change in the total area. | — |
Countries
Japan
Contacts
Public ContactMamoru Kikuchi
Saga University Hospital Department of Plastic and Reconstructive Surgery
Outcome results
None listed