Deformity, FootNCT04039308
Assessment of Surgical Correction of Deformity in Diabetic Charcot Arthropathy of the Foot and Ankle
An observational study of Deformity, Foot, run by Kerolos Maged.
Trial summary
The surgical techniques described in the literature for surgical management of diabetic charcot arthropathy of the foot and ankle include simple exostectomy, open reduction and internal fixation of neuropathic fractures, external fixation, arthrodesis, Achilles tendon lengthening. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Deformity, Foot
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to Sep 2020
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with deforming Charcot neuroarthropathy of the foot and ankle
Who may be able to join
- Patients with inactive form of Charcot arthropathy of the foot and ankle due to diabetes mellitus.
- Patients received surgical management.
Who cannot join
- Active form of Charcot arthropathy of the foot and ankle. Non deforming Charcot arthropathy of the foot and ankle. Patients with heavy infection or vascular affection that necessitate amputation.
Trial locations and contacts
No sites are listed yet.
About this study
The surgical techniques described in the literature for surgical management of diabetic charcot arthropathy of the foot and ankle include simple exostectomy, open reduction and internal fixation of neuropathic fractures, external fixation, arthrodesis, Achilles tendon lengthening. Patients are followed up at 1 year postoperative by an x-ray of the foot and ankle anteroposterior , lateral and oblique views to assess rate of union ,the correction of deformity by measuring the foot angles . The functional outcome is assessed by the AOFAS scoring system and the diabetic foot ulcer scaoeuulcer scale(18).
Read the detailed description
Diabetes mellitus affected approximately 422 million people worldwide in 2016 . Diabetic complications including diabetic peripheral neuropathy and peripheral arterial disease remain prevalent in the USA and worldwide and challenging to treat. Due to loss of protective sensation and impaired vascular supply, these can lead to serious foot complications including deformity, diabetic foot ulceration, Charcot neuroarthropathy and infection .
Charcot neuroarthropathy is a devastating orthopedic condition that afflicts patients with diabetes. It is an inflammatory condition that affects the foot and ankle with varying degrees of bone destruction and deformity. The true incidence or prevalence of this condition is not known.
However, estimates demonstrate incidence to be between 0.1 and 0.9%
. Two principal pathways for the disease have been proposed. The neurotraumatic theory suggests that the loss of neuroprotection causes repetitive microtrauma. The opposing hypothesis, the neurovascular, is that sympathetic neuropathy results in hyperaemia. This leads to increased osteoclastic activity resulting in bone resorption and fragmentation.
The active form of charcot foot arthropahy is often misdiagnosed as tenosynovitis, cellulitis, or gout. The majority of these patients endure a short period of disability that is treated by some form of immobilization for a variable period of time with minimal resultant long-term disability. The diagnosis is not often clear until resolution of the swelling when a resultant residual deformity is appreciated.
Eichenholtz classification is used to define Charcot foot clinical stages. Brodsky the classification, in the other hand, allows us to locate the lesion anatomically.
The incidence of diabetic neuroarthropathy varies among the anatomical regions of the foot and ankle according to Brodsky classification. Approximately 70% of cases affect the tarsometatarsal joint (type 1). Type-1 disease is the least likely to require surgical stabilization, although the most common type to cause plantar ulceration. Type-2 disease involves the midtarsal and subtalar joints and accounts for approximately 20% of cases. Type-3 disease affects approximately 10% of patients, and occurs mainly in the ankle. Type 2 and type 3 are the most likely to progress to instability and often require long-term bracing or surgical reconstruction.
The surgical techniques described in the literature include simple exostectomy, open reduction and internal fixation of neuropathic fractures, external fixation, arthrodesis, Achilles tendon lengthening and, eventually, amputation.The goal of Charcot neuroarthropathy treatment, both orthopedic and surgical is to obtain an ulcer free, stable plantigrade foot, without osteomyelitis and able to ambulate. Achieving these goals notably reduces the rate of amputations.
- Conditions
- Deformity, Foot
- Medical subject headings
- Foot Deformities
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative deformity correction in at least one- year postoperative follow up1x rays.
Assessment of accuracy of correction in patients with Charcot neuroarthropathy of the foot and ankle using follow up x rays and measuring the foot and ankle angles. The normal angles are documented, so we will compare these angles with the normal ones.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Deformity, FootStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerolos Maged
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kerolos Maged, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039308
- Sponsor's protocol ID
- Deformity in Charcot foot
- Status last verified
- Aug 2019
- First submitted
- 19 Jul 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1-World Health Organzation, Global report on diabetes .Geneva 2016
Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
PubMed 27999003Rogers LC, Frykberg RG, Armstrong DG, Boulton AJ, Edmonds M, Van GH, Hartemann A, Game F, Jeffcoate W, Jirkovska A, Jude E, Morbach S, Morrison WB, Pinzur M, Pitocco D, Sanders L, Wukich DK, Uccioli L. The Charcot foot in diabetes. Diabetes Care. 2011 Sep;34(9):2123-9. doi: 10.2337/dc11-0844.
PubMed 21868781Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort. Diabetes Care. 2003 May;26(5):1435-8. doi: 10.2337/diacare.26.5.1435.
PubMed 12716801Prompers L, Schaper N, Apelqvist J, Edmonds M, Jude E, Mauricio D, Uccioli L, Urbancic V, Bakker K, Holstein P, Jirkovska A, Piaggesi A, Ragnarson-Tennvall G, Reike H, Spraul M, Van Acker K, Van Baal J, Van Merode F, Ferreira I, Huijberts M. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008 May;51(5):747-55. doi: 10.1007/s00125-008-0940-0. Epub 2008 Feb 23.
PubMed 18297261El-Mowafi H, Abulsaad M, Kandil Y, El-Hawary A, Ali S. Hybrid Fixation for Ankle Fusion in Diabetic Charcot Arthropathy. Foot Ankle Int. 2018 Jan;39(1):93-98. doi: 10.1177/1071100717735074. Epub 2017 Oct 16.
PubMed 290355848-Eichenholtz SN. Charcot Joints. Springfield, IL, USA: Charles C. Thomas; 1966.
Brodsky JW. Management of Charcot joints of the foot and ankle in diabetes. Semin Arthroplasty. 1992; 3: 58-62.
Brodsky JW. Patterns of breakdown in the Charcot tarsus of diabetics and relation to treatment. Foot and Ankle 1986;5:353.
Lowery NJ, Woods JB, Armstrong DG, Wukich DK. Surgical management of Charcot neuroarthropathy of the foot and ankle: a systematic review. Foot Ankle Int. 2012 Feb;33(2):113-21. doi: 10.3113/FAI.2012.0113.
PubMed 22381342Anthony S., Pomeroy G. (2016) Exostectomy for Charcot Arthropathy. In: Herscovici, Jr. D. (eds) The Surgical Management of the Diabetic Foot and Ankle. Springer, Cham
Tan E.W., Schon L.C. (2016) Plate Fixation Techniques for Midfoot and Forefoot Charcot Arthropathy. In: Herscovici, Jr. D. (eds) The Surgical Management of the Diabetic Foot and Ankle. Springer, Cham
Use of External Fixation for the Management of the Diabetic Foot and AnkleDO - 10.1007/978-3-319-27623-6_13 - The Surgical Management of the Diabetic Foot and Ankle
Clinics in podiatric medicine and surgery, ISSN: 1558-2302, Vol: 34, Issue: 2, Page: 275-280 .2017
Gentili A, Masih S, Yao L, Seeger LL. Pictorial review: foot axes and angles. Br J Radiol. 1996 Oct;69(826):968-74. doi: 10.1259/0007-1285-69-826-968.
PubMed 9038535
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Surgical Correction of Deformity in Diabetic Charcot Arthropathy of the Foot and Ankle
- ClinicalTrials.gov ID
- NCT04039308
- Acronym / sponsor ID
- Deformity in Charcot foot
- Conditions
- Deformity, Foot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kerolos MagedUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 31 Jul 2019 (actual)
- 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.
The surgical techniques described in the literature for surgical management of diabetic charcot arthropathy of the foot and ankle include simple exostectomy, open reduction and internal fixation of neuropathic fractures, external fixation, arthrodesis, Achilles tendon lengthening. Patients are followed up at 1 year postoperative by an x-ray of the foot and ankle anteroposterior , lateral and oblique views to assess rate of union ,the correction of deformity by measuring the foot angles . The functional outcome is assessed by the AOFAS scoring system and the diabetic foot ulcer scaoeuulcer scale(18).
Detailed description
Diabetes mellitus affected approximately 422 million people worldwide in 2016 . Diabetic complications including diabetic peripheral neuropathy and peripheral arterial disease remain prevalent in the USA and worldwide and challenging to treat. Due to loss of protective sensation and impaired vascular supply, these can lead to serious foot complications including deformity, diabetic foot ulceration, Charcot neuroarthropathy and infection .
Charcot neuroarthropathy is a devastating orthopedic condition that afflicts patients with diabetes. It is an inflammatory condition that affects the foot and ankle with varying degrees of bone destruction and deformity. The true incidence or prevalence of this condition is not known.
However, estimates demonstrate incidence to be between 0.1 and 0.9%
. Two principal pathways for the disease have been proposed. The neurotraumatic theory suggests that the loss of neuroprotection causes repetitive microtrauma. The opposing hypothesis, the neurovascular, is that sympathetic neuropathy results in hyperaemia. This leads to increased osteoclastic activity resulting in bone resorption and fragmentation.
The active form of charcot foot arthropahy is often misdiagnosed as tenosynovitis, cellulitis, or gout. The majority of these patients endure a short period of disability that is treated by some form of immobilization for a variable period of time with minimal resultant long-term disability. The diagnosis is not often clear until resolution of the swelling when a resultant residual deformity is appreciated.
Eichenholtz classification is used to define Charcot foot clinical stages. Brodsky the classification, in the other hand, allows us to locate the lesion anatomically.
The incidence of diabetic neuroarthropathy varies among the anatomical regions of the foot and ankle according to Brodsky classification. Approximately 70% of cases affect the tarsometatarsal joint (type 1). Type-1 disease is the least likely to require surgical stabilization, although the most common type to cause plantar ulceration. Type-2 disease involves the midtarsal and subtalar joints and accounts for approximately 20% of cases. Type-3 disease affects approximately 10% of patients, and occurs mainly in the ankle. Type 2 and type 3 are the most likely to progress to instability and often require long-term bracing or surgical reconstruction.
The surgical techniques described in the literature include simple exostectomy, open reduction and internal fixation of neuropathic fractures, external fixation, arthrodesis, Achilles tendon lengthening and, eventually, amputation.The goal of Charcot neuroarthropathy treatment, both orthopedic and surgical is to obtain an ulcer free, stable plantigrade foot, without osteomyelitis and able to ambulate. Achieving these goals notably reduces the rate of amputations.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with deforming Charcot neuroarthropathy of the foot and ankle
Key inclusion criteria (2 listed)
- Patients with inactive form of Charcot arthropathy of the foot and ankle due to diabetes mellitus.
- Patients received surgical management.
Key exclusion criteria (1 listed)
- Active form of Charcot arthropathy of the foot and ankle. Non deforming Charcot arthropathy of the foot and ankle. Patients with heavy infection or vascular affection that necessitate amputation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of postoperative deformity correction in at least one- year postoperative follow up1x rays.
Time frame: 3 years
Assessment of accuracy of correction in patients with Charcot neuroarthropathy of the foot and ankle using follow up x rays and measuring the foot and ankle angles. The normal angles are documented, so we will compare these angles with the normal ones.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Background1-World Health Organzation, Global report on diabetes .Geneva 2016
- Background: PubMed 27999003Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
- Background: PubMed 21868781Rogers LC, Frykberg RG, Armstrong DG, Boulton AJ, Edmonds M, Van GH, Hartemann A, Game F, Jeffcoate W, Jirkovska A, Jude E, Morbach S, Morrison WB, Pinzur M, Pitocco D, Sanders L, Wukich DK, Uccioli L. The Charcot foot in diabetes. Diabetes Care. 2011 Sep;34(9):2123-9. doi: 10.2337/dc11-0844.
- Background: PubMed 12716801Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort. Diabetes Care. 2003 May;26(5):1435-8. doi: 10.2337/diacare.26.5.1435.
- Background: PubMed 18297261Prompers L, Schaper N, Apelqvist J, Edmonds M, Jude E, Mauricio D, Uccioli L, Urbancic V, Bakker K, Holstein P, Jirkovska A, Piaggesi A, Ragnarson-Tennvall G, Reike H, Spraul M, Van Acker K, Van Baal J, Van Merode F, Ferreira I, Huijberts M. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008 May;51(5):747-55. doi: 10.1007/s00125-008-0940-0. Epub 2008 Feb 23.
- Background: PubMed 29035584El-Mowafi H, Abulsaad M, Kandil Y, El-Hawary A, Ali S. Hybrid Fixation for Ankle Fusion in Diabetic Charcot Arthropathy. Foot Ankle Int. 2018 Jan;39(1):93-98. doi: 10.1177/1071100717735074. Epub 2017 Oct 16.
- Background8-Eichenholtz SN. Charcot Joints. Springfield, IL, USA: Charles C. Thomas; 1966.
- BackgroundBrodsky JW. Management of Charcot joints of the foot and ankle in diabetes. Semin Arthroplasty. 1992; 3: 58-62.
- BackgroundBrodsky JW. Patterns of breakdown in the Charcot tarsus of diabetics and relation to treatment. Foot and Ankle 1986;5:353.
- Background: PubMed 22381342Lowery NJ, Woods JB, Armstrong DG, Wukich DK. Surgical management of Charcot neuroarthropathy of the foot and ankle: a systematic review. Foot Ankle Int. 2012 Feb;33(2):113-21. doi: 10.3113/FAI.2012.0113.
- BackgroundAnthony S., Pomeroy G. (2016) Exostectomy for Charcot Arthropathy. In: Herscovici, Jr. D. (eds) The Surgical Management of the Diabetic Foot and Ankle. Springer, Cham
- BackgroundTan E.W., Schon L.C. (2016) Plate Fixation Techniques for Midfoot and Forefoot Charcot Arthropathy. In: Herscovici, Jr. D. (eds) The Surgical Management of the Diabetic Foot and Ankle. Springer, Cham
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Deformity, Foot, run by Kerolos Maged.
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 2 inclusion and 1 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 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Kerolos Maged, MBBCH (+201063692926, Kerolosmaged230@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postoperative deformity correction in at least one- year postoperative follow up1x rays. (time frame: 3 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 NCT04039308, which also lists 18 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 30 Aug 2019.