Clinical trial NCT03010215: Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery
Official title: Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetic Foot
Diabetic Foot Infection
Diabetic Foot Ulcer Neuropathic
Deformities Foot
Keywords: Minimally Invasive Surgery
Percutaneous distal osteotomy
Distal Metatarsal Minimally-invasive Osteotomy (DMMO)
Percutaneous Tenotomy
Forefoot
Metatarsal bones
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale
timeFrame: From 1 month before the operation until study completion, an average of 2 years.
Secondary outcomes:
measure: Radiological outcomes changes after surgical treatment
timeFrame: Preoperative and at 3-6-12 months post-operative
measure: Change in clinical evaluation with SF-36 score
timeFrame: From 1 month before the operation until study completion, an average of 2 years.
measure: Change in clinical evaluation with VAS
timeFrame: From 1 month before the operation until study completion, an average of 2 years.
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Orthopaedic Clinic, Padua University
state: PD
Study officials:
affiliation: University of Padova
name: Carlo Biz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biz C, Fosser M, Dalmau-Pastor M, Corradin M, Roda 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 study with a 48-month follow-up. J Orthop Surg Res. 2016 Dec 5;11(1):157. doi: 10.1186/s13018-016-0491-x.
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.
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.
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. Epub 2011 Aug 27.