Natural History of Pedal Puncture Wounds in Diabetics

NCT ID: NCT01151891

Last Updated: 2011-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-12-31

Brief Summary

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There are no evidence (research) based guidelines for treatment of early, closed puncture wounds of the feet in diabetics. Surgeons usually see only the limb- and life-threatening consequences of puncture wounds of the feet in diabetics, and are therefore tempted to advocate more aggressive, preemptive, invasive primary treatment for all such wounds, assuming, from this blinkered perspective that all such wounds progress to serious infection. This study is designed to determine the natural history of puncture wounds of the feet in diabetics, specifically, whether all become infected or whether some do heal without any surgical intervention. It requires administration of a questionnaire to 188 known diabetics attending 11 selected outpatient health care centers in the parish of St. James, Jamaica.

Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diabetics

Diabetics in the parish of St. James, Jamaica

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diabetic
* 15 years and older
* Resident in the parish of St. James, Jamaica

Exclusion Criteria

* Impairment of conscious level or mental status such that autonomy is compromised
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. James Health Department

UNKNOWN

Sponsor Role collaborator

Private Practice of Dr. Hector Robinson

UNKNOWN

Sponsor Role collaborator

Private Practice of Dr. Curtis Yeates

UNKNOWN

Sponsor Role collaborator

Cornwall Regional Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Cornwall Regional Hospital

Principal Investigators

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Jeffrey M East, MD

Role: PRINCIPAL_INVESTIGATOR

Cornwall Regional Hospital

Locations

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Cornwall Regional Hospital

Montego Bay, Saint James Parish, Jamaica

Site Status

Health Centers of the St. James Health Department

Montego Bay, Saint James Parish, Jamaica

Site Status

Private clinic of Dr. Curtis Yeates

Montego Bay, Saint James Parish, Jamaica

Site Status

Private clinic of Dr. Hector Robinson

Montego Bay, Saint James Parish, Jamaica

Site Status

Countries

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Jamaica

References

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Wilks RJ, Sargeant LA, Gulliford MC, Reid ME, Forrester TE. Management of diabetes mellitus in three settings in Jamaica. Rev Panam Salud Publica. 2001 Feb;9(2):65-72. doi: 10.1590/s1020-49892001000200002.

Reference Type BACKGROUND
PMID: 11293831 (View on PubMed)

Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5.

Reference Type BACKGROUND
PMID: 17280936 (View on PubMed)

Fitzgerald RH Jr, Cowan JD. Puncture wounds of the foot. Orthop Clin North Am. 1975 Oct;6(4):965-72.

Reference Type BACKGROUND
PMID: 241038 (View on PubMed)

Joseph WS, LeFrock JL. Infections complicating puncture wounds of the foot. J Foot Surg. 1987 Jan-Feb;26(1 Suppl):S30-3.

Reference Type BACKGROUND
PMID: 2881957 (View on PubMed)

Verdile VP, Freed HA, Gerard J. Puncture wounds to the foot. J Emerg Med. 1989 Mar-Apr;7(2):193-9. doi: 10.1016/0736-4679(89)90269-2.

Reference Type BACKGROUND
PMID: 2567749 (View on PubMed)

Weber EJ. Plantar puncture wounds: a survey to determine the incidence of infection. J Accid Emerg Med. 1996 Jul;13(4):274-7. doi: 10.1136/emj.13.4.274.

Reference Type BACKGROUND
PMID: 8832349 (View on PubMed)

Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BA. Risk factors for foot infections in individuals with diabetes. Diabetes Care. 2006 Jun;29(6):1288-93. doi: 10.2337/dc05-2425.

Reference Type BACKGROUND
PMID: 16732010 (View on PubMed)

Wright-Pascoe R, Roye-Green K, Bodonaik N. The medical management of diabetes mellitus with particular reference to the lower extremity: the Jamaican experience. West Indian Med J. 2001 Mar 1-4;50 Suppl 1:46-9.

Reference Type BACKGROUND
PMID: 15973818 (View on PubMed)

East JM, Yeates CB, Robinson HP. The natural history of pedal puncture wounds in diabetics: a cross-sectional survey. BMC Surg. 2011 Oct 17;11:27. doi: 10.1186/1471-2482-11-27.

Reference Type DERIVED
PMID: 22004373 (View on PubMed)

Other Identifiers

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JE-2

Identifier Type: -

Identifier Source: org_study_id

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