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Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery (DiabeticMIS1)

Primary Purpose

Diabetic Foot Ulcer, Diabetic Foot, Diabetic Foot Infection

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Distal Metatarsal Minimally invasive Osteotomy (DMMO)
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Minimally Invasive Surgery, Percutaneous distal osteotomy, Distal Metatarsal Minimally-invasive Osteotomy (DMMO), Percutaneous Tenotomy, Forefoot, Metatarsal bones

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orthopaedic Clinic, Padua University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Minimally Invasive Surgery (MIS)

Arm Description

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

Outcomes

Primary Outcome Measures

Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale
Total between 0 to 100.

Secondary Outcome Measures

Radiological outcomes changes after surgical treatment
Evaluation of the Maestro Criteria and the bridging bone/callus formation.
Change in clinical evaluation with SF-36 score
Change in clinical evaluation with VAS

Full Information

First Posted
December 20, 2016
Last Updated
January 2, 2017
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT03010215
Brief Title
Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery
Acronym
DiabeticMIS1
Official Title
Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimally Invasive Surgery (MIS)
Arm Type
Other
Arm Description
Patients with plantar chronic diabetic foot ulcers will be treated by Distal Metatarsal Minimally invasive Osteotomy (DMMO).
Intervention Type
Other
Intervention Name(s)
Distal Metatarsal Minimally invasive Osteotomy (DMMO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale
Description
Total between 0 to 100.
Time Frame
From 1 month before the operation until study completion, an average of 2 years.
Secondary Outcome Measure Information:
Title
Radiological outcomes changes after surgical treatment
Description
Evaluation of the Maestro Criteria and the bridging bone/callus formation.
Time Frame
Preoperative and at 3-6-12 months post-operative
Title
Change in clinical evaluation with SF-36 score
Time Frame
From 1 month before the operation until study completion, an average of 2 years.
Title
Change in clinical evaluation with VAS
Time Frame
From 1 month before the operation until study completion, an average of 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Biz, MD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Clinic, Padua University
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Age, Gender, Radiological and Clinica parameters and images.
Citations:
PubMed Identifier
27919259
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.
Results Reference
result
PubMed Identifier
27401772
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.
Results Reference
result
PubMed Identifier
19336809
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.
Results Reference
result
PubMed Identifier
21873138
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.
Results Reference
result

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Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

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