Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

Diabetic Foot Ulcer Clinical Trial

— DiabeticMIS1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03010215
• Other study ID #: DiabeticMIS01
• Status: Active, not recruiting
• Phase: N/A
• First received: December 20, 2016
• Last updated: January 2, 2017
• Start date: January 2010
• Est. completion date: December 2020

Study information

• Verified date: January 2017
• Source: University of Padua
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deformities Foot
• Diabetic Foot
• Diabetic Foot Infection
• Diabetic Foot Ulcer
• Diabetic Foot Ulcer Neuropathic
• Foot Deformities
• Foot Ulcer
• Ulcer

Intervention

Other:
• Distal Metatarsal Minimally invasive Osteotomy (DMMO)
Percutaneous dorsal incision at the level of the the distal part of the metatarsal bone, a Shannon burr is introduced at the level of metatarsal neck, with orientation of at approximately 45°, keeping the articular cartilage surface of the metatarsal head as reference point on the superior cortex. In this position, under fluoroscopic control, the osteotomy is started following a distal-dorsal and proximal-plantar direction. In this way the metatarsal head moves proximally and dorsally reducing the metatarsal pressure on the plantar ulcer.

Locations

Country	Name	City	State
Italy	Orthopaedic Clinic, Padua University	Padova	PD

Sponsors (1)

Lead Sponsor	Collaborator
University of Padua

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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

Outcome

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