Clinical Trial: Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study

Brief Summary:

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.


Detailed Summary: Thirty-two patients with chronic diabetic foot ulcers (CDFUs) were treated by MIS between January 2010 and September 2016. Clinical evaluation was assessed pre-operatively, as well as at 3 months after surgery and at final follow-up, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale. The recurrence of the ulcers and complications were recorded. All the ulcers were evaluated with the University of Texas Diabetic Wound Classification. We used the radiological Maestro's criteria to evaluated the radiographs before and after the operation. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency. The global disability was evaluated with the Short Form Health Survey (SF-36) and the satisfaction's level with the Visual Analogue Scale (VAS). Statistical analysis was carried out using the Wilcoxon signed-rank test. Statistical significance was set at p < 0.05.
Sponsor: University of Padua

Current Primary Outcome: Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale [ Time Frame: From 1 month before the operation until study completion, an average of 2 years. ]

Total between 0 to 100.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Radiological outcomes changes after surgical treatment [ Time Frame: Preoperative and at 3-6-12 months post-operative ]
    Evaluation of the Maestro Criteria and the bridging bone/callus formation.
  • Change in clinical evaluation with SF-36 score [ Time Frame: From 1 month before the operation until study completion, an average of 2 years. ]
  • Change in clinical evaluation with VAS [ Time Frame: From 1 month before the operation until study completion, an average of 2 years. ]


Original Secondary Outcome: Same as current

Information By: University of Padua

Dates:
Date Received: December 20, 2016
Date Started: January 2010
Date Completion: December 2020
Last Updated: January 2, 2017
Last Verified: January 2017