NCT04039308

Brief 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. 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

July 19, 2019

Last Update Submit

August 29, 2019

Conditions

Deformity, Foot

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with deforming Charcot neuroarthropathy of the foot and ankle

You may qualify if:

  • Patients with inactive form of Charcot arthropathy of the foot and ankle due to diabetes mellitus.
  • Patients received surgical management.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • 1-World Health Organzation, Global report on diabetes .Geneva 2016

    BACKGROUND

  • 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.

    PMID: 27999003BACKGROUND

  • Rogers 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.

    PMID: 21868781BACKGROUND

  • Lavery 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.

    PMID: 12716801BACKGROUND

  • Prompers 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.

    PMID: 18297261BACKGROUND

  • El-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.

    PMID: 29035584BACKGROUND

  • 8-Eichenholtz SN. Charcot Joints. Springfield, IL, USA: Charles C. Thomas; 1966.

    BACKGROUND

  • Brodsky JW. Management of Charcot joints of the foot and ankle in diabetes. Semin Arthroplasty. 1992; 3: 58-62.

    BACKGROUND

  • Brodsky JW. Patterns of breakdown in the Charcot tarsus of diabetics and relation to treatment. Foot and Ankle 1986;5:353.

    BACKGROUND

  • 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.

    PMID: 22381342BACKGROUND

  • Anthony S., Pomeroy G. (2016) Exostectomy for Charcot Arthropathy. In: Herscovici, Jr. D. (eds) The Surgical Management of the Diabetic Foot and Ankle. Springer, Cham

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • Clinics in podiatric medicine and surgery, ISSN: 1558-2302, Vol: 34, Issue: 2, Page: 275-280 .2017

    BACKGROUND

  • 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.

    PMID: 9038535BACKGROUND

  • Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701.

    PMID: 7951968BACKGROUND

  • 18-Abetz L, Sutton M, Brady L, McNulty P, Gagnon DD. The diabetic foot ulcer scale (DFS): a quality of life instrument for use in clinical trials. Prac Diabetes Int. 2002;19:167-175.

    BACKGROUND

  • Robinson AH, Pasapula C, Brodsky JW. Surgical aspects of the diabetic foot. J Bone Joint Surg Br. 2009 Jan;91(1):1-7. doi: 10.1302/0301-620X.91B1.21196.

    PMID: 19091997RESULT

MeSH Terms

Conditions

Foot Deformities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Central Study Contacts

Kerolos Maged, MBBCH

CONTACT

+201063692926Kerolosmaged230@gmail.com

Ahmed Othman, MD

CONTACT

+20102756356ah_911@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident of Orthopedics and traumatology

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 31, 2019

Study Start

October 1, 2019

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

August 30, 2019

Record last verified: 2019-08