Diabetic Foot Ulcer Clinical Trial
— DiabeticMIS1Official title:
Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study
Verified date | January 2017 |
Source | University of Padua |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Despite the development of the control of DM and the great interest for the complications of
the disease, even today the diabetic foot represents a challenge for the orthopaedic
surgeon. Being frequently correlated to alteration of the plantar pressures, the surgery
treatment is recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve
this pathologic case.
The purpose of this longitudinal cross-sectional study was to evaluate radiographic and
surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis
of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic
through MIS.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | December 2020 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of DM; - presence of a plantar CDFU, so not healed after 6 months of medical multidisciplinary treatment; - HbA1c < 8,5%. Exclusion Criteria: - congenital deformities of the foot; - macroscopic signs of local infection of the soft tissues; - alteration of CRP>150 mg/L; - previous foot and ankle surgery; - previous foot and ankle surgery; - rheumatic, neurologic, infective, or psychiatric pathologies. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Orthopaedic Clinic, Padua University | Padova | PD |
Lead Sponsor | Collaborator |
---|---|
University of Padua |
Italy,
Biz C, Fosser M, Dalmau-Pastor M, Corradin M, Rodà MG, Aldegheri R, Ruggieri P. Functional and radiographic outcomes of hallux valgus correction by mini-invasive surgery with Reverdin-Isham and Akin percutaneous osteotomies: a longitudinal prospective stu — View Citation
Dayer R, Assal M. Chronic diabetic ulcers under the first metatarsal head treated by staged tendon balancing: a prospective cohort study. J Bone Joint Surg Br. 2009 Apr;91(4):487-93. doi: 10.1302/0301-620X.91B4.21598. — View Citation
Henry J, Besse JL, Fessy MH; AFCP.. Distal osteotomy of the lateral metatarsals: a series of 72 cases comparing the Weil osteotomy and the DMMO percutaneous osteotomy. Orthop Traumatol Surg Res. 2011 Oct;97(6 Suppl):S57-65. doi: 10.1016/j.otsr.2011.07.003 — View Citation
Tamir E, Finestone AS, Avisar E, Agar G. Mini-Invasive floating metatarsal osteotomy for resistant or recurrent neuropathic plantar metatarsal head ulcers. J Orthop Surg Res. 2016 Jul 11;11(1):78. doi: 10.1186/s13018-016-0414-x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale | Total between 0 to 100. | From 1 month before the operation until study completion, an average of 2 years. | Yes |
Secondary | Radiological outcomes changes after surgical treatment | Evaluation of the Maestro Criteria and the bridging bone/callus formation. | Preoperative and at 3-6-12 months post-operative | Yes |
Secondary | Change in clinical evaluation with SF-36 score | From 1 month before the operation until study completion, an average of 2 years. | Yes | |
Secondary | Change in clinical evaluation with VAS | From 1 month before the operation until study completion, an average of 2 years. | Yes |
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