Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

NCT03010215 | Unknown

• 1 other identifier: DiabeticMIS01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Radiological outcomes changes after surgical treatment

  Preoperative and at 3-6-12 months post-operative

• Change in clinical evaluation with SF-36 score

  From 1 month before the operation until study completion, an average of 2 years.

• Change in clinical evaluation with VAS

  From 1 month before the operation until study completion, an average of 2 years.

Study Arms (1)

Minimally Invasive Surgery (MIS)

OTHER

Patients with plantar chronic diabetic foot ulcers will be treated by Distal Metatarsal Minimally invasive Osteotomy (DMMO).

Other: Distal Metatarsal Minimally invasive Osteotomy (DMMO)

Interventions

Distal Metatarsal Minimally invasive Osteotomy (DMMO) OTHER

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.

Minimally Invasive Surgery (MIS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of DM;
• presence of a plantar CDFU, so not healed after 6 months of medical multidisciplinary treatment;
• HbA1c \< 8,5%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Orthopaedic Clinic, Padua University

Padua, PD, 35128, Italy

Location

Related Publications (4)

• 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.

  PMID: 27919259 RESULT

• 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.

  PMID: 27401772 RESULT

• 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.

  PMID: 19336809 RESULT

• 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.

  PMID: 21873138 RESULT

MeSH Terms

Conditions

Diabetic Foot; Foot Deformities

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Musculoskeletal Diseases

Study Officials

• Carlo Biz, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 4, 2017
• Study Start: January 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2020
• Last Updated: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)