Natural History of Pedal Puncture Wounds in Diabetics

Diabetes Clinical Trial

Official title:

The Natural History of Pedal Puncture Wounds in Diabetics: a Cross-sectional Survey in the Parish of St. James, Jamaica.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151891
• Other study ID #: JE-2
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: January 11, 2011
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Cornwall Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jamaica: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
Jamaica	Cornwall Regional Hospital	Montego Bay	St. James
Jamaica	Health Centers of the St. James Health Department	Montego Bay	St. James
Jamaica	Private clinic of Dr. Curtis Yeates	Montego Bay	St. James
Jamaica	Private clinic of Dr. Hector Robinson	Montego Bay	St. James

Sponsors (4)

Lead Sponsor	Collaborator
Cornwall Regional Hospital	Private Practice of Dr. Curtis Yeates, Private Practice of Dr. Hector Robinson, St. James Health Department

Country where clinical trial is conducted

Jamaica, 

References & Publications (8)

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

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. — View Citation

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

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. — View Citation

Verdile VP, Freed HA, Gerard J. Puncture wounds to the foot. J Emerg Med. 1989 Mar-Apr;7(2):193-9. Review. — View Citation

Weber EJ. Plantar puncture wounds: a survey to determine the incidence of infection. J Accid Emerg Med. 1996 Jul;13(4):274-7. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pedal puncture wounds		September, 2010	No
Secondary	Infection in pedal puncture wounds		September, 2010	No