Clinical trial NCT01151891: Natural History of Pedal Puncture Wounds in Diabetics
Official title: The Natural History of Pedal Puncture Wounds in Diabetics: a Cross-sectional Survey in the Parish of St. James, Jamaica.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Pedal puncture wounds
Infection in pedal puncture wounds
Diabetes education and pedal puncture wounds
Lead sponsor: Cornwall Regional Hospital
Sponsor class: OTHER_GOV
Collaborators: name: St. James Health Department
name: Private Practice of Dr. Hector Robinson
name: Private Practice of Dr. Curtis Yeates
First posted: 2010-06-29
Enrollment: 188
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetics attending 3 public hospital outpatient clinics, 6 public Health Center primary care clinics and 2 private Internist's clinics.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pedal puncture wounds
timeFrame: September, 2010
Secondary outcomes:
measure: Infection in pedal puncture wounds
timeFrame: September, 2010
Other outcomes:
Locations:
city: Montego Bay
country: Jamaica
facility: Cornwall Regional Hospital
state: St. James
city: Montego Bay
country: Jamaica
facility: Health Centers of the St. James Health Department
state: St. James
city: Montego Bay
country: Jamaica
facility: Private clinic of Dr. Curtis Yeates
state: St. James
city: Montego Bay
country: Jamaica
facility: Private clinic of Dr. Hector Robinson
state: St. James
Study officials:
affiliation: Cornwall Regional Hospital
name: Jeffrey M East, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1590/s1020-49892001000200002.
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. doi: 10.1016/S1067-2516(07)60001-5.
citation: Fitzgerald RH Jr, Cowan JD. Puncture wounds of the foot. Orthop Clin North Am. 1975 Oct;6(4):965-72.
citation: Joseph WS, LeFrock JL. Infections complicating puncture wounds of the foot. J Foot Surg. 1987 Jan-Feb;26(1 Suppl):S30-3.
citation: 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.
citation: 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.
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. doi: 10.2337/dc05-2425.
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.
citation: 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.