Diabetic Foot UlcerDiabeticMIS1NCT03010215
Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery
A study testing Distal Metatarsal Minimally invasive Osteotomy (DMMO) in people with Diabetic Foot Ulcer and Diabetic Foot, run by University of Padova at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot, Diabetic Foot Infection
- What is being tested?
- Distal Metatarsal Minimally invasive Osteotomy (DMMO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of DM;
- presence of a plantar CDFU, so not healed after 6 months of medical multidisciplinary treatment;
- HbA1c < 8,5%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Diabetic Foot Infection, Diabetic Foot Ulcer Neuropathic, Deformities Foot
- Being tested
- Distal Metatarsal Minimally invasive Osteotomy (DMMO)
- Keywords
- Minimally Invasive Surgery, Percutaneous distal osteotomy, Distal Metatarsal Minimally-invasive Osteotomy (DMMO), Percutaneous Tenotomy, Forefoot, Metatarsal bones
- Medical subject headings
- Diabetic Foot, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Surgery (MIS) | Other | Patients with plantar chronic diabetic foot ulcers will be treated by Distal Metatarsal Minimally invasive Osteotomy (DMMO). Receives: Other: Distal Metatarsal Minimally invasive Osteotomy (DMMO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale
Total between 0 to 100.
Measured: From 1 month before the operation until study completion, an average of 2 years.
Secondary outcomes (3)
Radiological outcomes changes after surgical treatment
Evaluation of the Maestro Criteria and the bridging bone/callus formation.
Measured: Preoperative and at 3-6-12 months post-operative
Change in clinical evaluation with SF-36 score
Measured: From 1 month before the operation until study completion, an average of 2 years.
Change in clinical evaluation with VAS
Measured: From 1 month before the operation until study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2010
- Primary completionSep 2016
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Biz, University of Padova
- Investigators
- Carlo Biz, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010215
- Sponsor's protocol ID
- DiabeticMIS01
- Acronym
- DiabeticMIS1
- Status last verified
- Jan 2017
- First submitted
- 20 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Age, Gender, Radiological and Clinica parameters and images.
Publications
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.
PubMed 27919259Tamir 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.
PubMed 27401772Dayer 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.
PubMed 19336809Henry 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.
PubMed 21873138
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03010215
- Acronym / sponsor ID
- DiabeticMIS1 / DiabeticMIS01
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Surgery (MIS) | Other | Other: Distal Metatarsal Minimally invasive Osteotomy (DMMO)Patients with plantar chronic diabetic foot ulcers will be treated by Distal Metatarsal Minimally invasive Osteotomy (DMMO). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of DM;
- presence of a plantar CDFU, so not healed after 6 months of medical multidisciplinary treatment;
- HbA1c < 8,5%.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Minimally Invasive Surgery (MIS) |
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.
3 secondary outcomes
Radiological outcomes changes after surgical treatment
Time frame: Preoperative and at 3-6-12 months post-operative
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Results publication: PubMed 27919259Biz 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 publication: PubMed 27401772Tamir 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 publication: PubMed 19336809Dayer 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 publication: PubMed 21873138Henry 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.
- Individual participant dataSharing planned: Yes. Age, Gender, Radiological and Clinica parameters and images.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Biz, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal Metatarsal Minimally invasive Osteotomy (DMMO) in people with Diabetic Foot Ulcer and Diabetic Foot, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03010215, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.