DiabetesNCT01151891
Natural History of Pedal Puncture Wounds in Diabetics
An observational study of Diabetes, run by Cornwall Regional Hospital at 4 sites in Jamaica.
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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Diabetes
- How many people
- 188 participants
- Where
- 4 sitesJamaica
- Study dates
- Jun 2010to Dec 2010
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetics attending 3 public hospital outpatient clinics, 6 public Health Center primary care clinics and 2 private Internist's clinics.
Who may be able to join
- Diabetic
- 15 years and older
- Resident in the parish of St. James, Jamaica
Who cannot join
- Impairment of conscious level or mental status such that autonomy is compromised
Trial locations and contacts
4 sites in 1 country.
Jamaica4 sites
Cornwall Regional Hospital
Montego Bay, Saint James Parish
Health Centers of the St. James Health Department
Montego Bay, Saint James Parish
Private clinic of Dr. Curtis Yeates
Montego Bay, Saint James Parish
Private clinic of Dr. Hector Robinson
Montego Bay, Saint James Parish
About this study
Official title: The Natural History of Pedal Puncture Wounds in Diabetics: a Cross-sectional Survey in the Parish of St. James, Jamaica.
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.
- Conditions
- Diabetes
- Keywords
- Pedal puncture wounds, Infection in pedal puncture wounds, Diabetes education and pedal puncture wounds
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetics | Diabetics in the parish of St. James, Jamaica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedal puncture wounds
Measured: September, 2010
Secondary outcomes (1)
Infection in pedal puncture wounds
Measured: September, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Cross-sectional
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornwall Regional Hospital
- Sponsor type
- Other government
- Collaborators
- St. James Health Department, Private Practice of Dr. Hector Robinson, Private Practice of Dr. Curtis Yeates
- Investigators
- Jeffrey M East, MD, Principal investigator, Cornwall Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151891
- Sponsor's protocol ID
- JE-2
- Status last verified
- Jan 2011
- First submitted
- 28 Jun 2010
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11293831Frykberg 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.
PubMed 17280936Fitzgerald RH Jr, Cowan JD. Puncture wounds of the foot. Orthop Clin North Am. 1975 Oct;6(4):965-72.
PubMed 241038Joseph WS, LeFrock JL. Infections complicating puncture wounds of the foot. J Foot Surg. 1987 Jan-Feb;26(1 Suppl):S30-3.
PubMed 2881957Verdile 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.
PubMed 2567749Weber 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.
PubMed 8832349Lavery 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.
PubMed 16732010Wright-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.
PubMed 15973818East 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.
PubMed 22004373
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Pedal Puncture Wounds in Diabetics: a Cross-sectional Survey in the Parish of St. James, Jamaica.
- ClinicalTrials.gov ID
- NCT01151891
- Acronym / sponsor ID
- JE-2
- Conditions
- Diabetes
- Keywords
- Pedal puncture wounds, Infection in pedal puncture wounds, Diabetes education and pedal puncture wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Cornwall Regional HospitalOther government
- Collaborators
- St. James Health Department, Private Practice of Dr. Hector Robinson, Private Practice of Dr. Curtis Yeates
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jun 2010 (estimated)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetics | – | –Diabetics in the parish of St. James, Jamaica |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetics attending 3 public hospital outpatient clinics, 6 public Health Center primary care clinics and 2 private Internist's clinics.
Key inclusion criteria (3 listed)
- Diabetic
- 15 years and older
- Resident in the parish of St. James, Jamaica
Key exclusion criteria (1 listed)
- Impairment of conscious level or mental status such that autonomy is compromised
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
Pedal puncture wounds
Time frame: September, 2010
1 secondary outcome
Infection in pedal puncture wounds
Time frame: September, 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2011.
- Background: PubMed 11293831Wilks 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.
- Background: PubMed 17280936Frykberg 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.
- Background: PubMed 241038Fitzgerald RH Jr, Cowan JD. Puncture wounds of the foot. Orthop Clin North Am. 1975 Oct;6(4):965-72.
- Background: PubMed 2881957Joseph WS, LeFrock JL. Infections complicating puncture wounds of the foot. J Foot Surg. 1987 Jan-Feb;26(1 Suppl):S30-3.
- Background: PubMed 2567749Verdile 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.
- Background: PubMed 8832349Weber 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.
- Background: PubMed 16732010Lavery 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.
- Background: PubMed 15973818Wright-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.
- Derived from this study: PubMed 22004373East 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.
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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.
Jeffrey M East, MD principal investigator
Cornwall Regional Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Cornwall Regional Hospital at 4 sites in Jamaica.
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 3 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: finished, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pedal puncture wounds (time frame: September, 2010). 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 NCT01151891, which also lists 9 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 12 Jan 2011.