Diabetes ComplicationsNCT03426566

Abnormal Plantar Pressure in Patients With Diabetes

An observational study of Diabetes Complications, run by Wroclaw Medical University at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The prevalence of abnormal plantar pressure distribution (APD) and its connection with various factors among patients with diabetes is not known. The purpose of this study was to evaluate the prevalence of the APD and its connection with selected factors among patients with diabetes. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Diabetes Complications
How many people: 974 participants
Where: 1 sitePoland
Study dates: Sep 2012to Jan 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Wroclaw (where the Diabetic Foot Centre exists) citizens who came spontaneously to be examined despite the absence of diabetic foot signs or symptoms

Who may be able to join

subjects with diabetes mellitus diagnosis
citizens
no previous foot ulceration and/or foot surgery

Who cannot join

previous foot ulceration and/or foot surgery

Trial locations and contacts

1 site in 1 country.

Poland1 site

Department and Division of Medical Rehabilitation
Wroclaw, Lower Silesian Voivodeship, 54-438

Other trials in Poland

About this study

Official title: Prevention of Foot Injuries - Abnormal Distribution Patterns of Plantar Pressure in Patients With Diabetes and Its Connection to Peripheral Neuropathy, Gender, Age and BMI

Read the detailed description

The abnormal plantar pressure distribution (APD) plays a key role in the formation of plantar calluses which are responsible for diabetic foot ulcer.

The knowledge of APD is necessary to plan proper prevention in the group of patients with diabetes mellitus (DM).

Medical records from previous patients' visits of non-ulcer patients with diabetes were retrospectively analysed. The relationship between APD, obtained during a pedobarographic test as a semi-quantitative assessment with colourful print analysis, and neuropathy, gender, age and BMI was searched.

Conditions: Diabetes Complications
Being tested: retrospective observational study with no intervention
Keywords: diabetic foot, pedobarography, diabetic neuropathy, plantar pressure
Medical subject headings: Diabetes Complications, Diabetic Foot, Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

retrospective observational study with no interventionOther
no intervention

Study groups in NCT03426566
Study group	Role	What they receive
patients with diabetes		Data from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned. Receives: Other: retrospective observational study with no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Abnormal Plantar Pressure Distribution
static pedobarographic test with semi-quantitative assessment: number of the patients with abnormal plantar pressure location based on a semi-quantitative method, as static barefoot pedobarographic records with colourful print analysis. The intensity of colour was proportional to the pressure received. Warm colours indicated the greatest pressure, while cold colours indicated the least plantar pressure (starting with red, then yellow, green, and blue)
Measured: 1 visit

Secondary outcomes (2)

Number of Participants With Positive Test for Neuropathy
Peripheral neuropathy is assessed with questions and clinical evaluation. A nurse asks the patient about stinging, numbness, tingling, or burning of the foot. Ten-gram monofilament and tuning fork (128 MHz) tests are administered. Monofilament is applied in 10 locations on the sole and one on the dorsal part of the foot for checking the loss of protective sensation. A positive monofilament test is considered to be the lack of sensation of tightness in at least 6 of 11 tested sites. The tuning fork is applied for vibration detection to both ankles, the first metatarsophalangeal joint, and the anterior aspect of the shin bone sites. A positive vibration test is considered to be no detection of vibration in three of four test sites.Two positive test results and typical symptoms of neuropathy are the basis for confirmation of peripheral symmetric sensory neuropathy (PSSN). The condition required for the occurrence of these disorders was symmetry.
Measured: 1 visit
BMI
kg/m2
Measured: 1 visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Jan 2014

First posted8 Feb 2018
Study startSep 2012
Primary completionDec 2012
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Diabetes ComplicationsStudies 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: Other
Time perspective: Retrospective
Enrolment: 974 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03426566
Sponsor's protocol ID: ST 690
Status last verified: May 2022
First submitted: 23 Jan 2018
Last updated: 27 May 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: all collected individual participant data but without individual foot-print picture (mostly paper documentation) ; only the example of foot -print with explanation is available

Publications

Boulton AJ, Hardisty CA, Betts RP, Franks CI, Worth RC, Ward JD, Duckworth T. Dynamic foot pressure and other studies as diagnostic and management aids in diabetic neuropathy. Diabetes Care. 1983 Jan-Feb;6(1):26-33. doi: 10.2337/diacare.6.1.26.
PubMed 6839919
Boulton AJ, Betts RP, Franks CI, Newrick PG, Ward JD, Duckworth T. Abnormalities of foot pressure in early diabetic neuropathy. Diabet Med. 1987 May-Jun;4(3):225-8. doi: 10.1111/j.1464-5491.1987.tb00867.x.
PubMed 2956023
Duckworth T, Boulton AJ, Betts RP, Franks CI, Ward JD. Plantar pressure measurements and the prevention of ulceration in the diabetic foot. J Bone Joint Surg Br. 1985 Jan;67(1):79-85. doi: 10.1302/0301-620X.67B1.3968150.
PubMed 3968150
Rich J, Veves A. Forefoot and rearfoot plantar pressures in diabetic patients: correlation to foot ulceration. Wounds2000;12:82-87
Frykberg RG, Lavery LA, Pham H, Harvey C, Harkless L, Veves A. Role of neuropathy and high foot pressures in diabetic foot ulceration. Diabetes Care. 1998 Oct;21(10):1714-9. doi: 10.2337/diacare.21.10.1714.
PubMed 9773736
Bakker K, Schaper NC; International Working Group on Diabetic Foot Editorial Board. The development of global consensus guidelines on the management and prevention of the diabetic foot 2011. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:116-8. doi: 10.1002/dmrr.2254.
PubMed 22271736
Choi YR, Lee HS, Kim DE, Lee DH, Kim JM, Ahn JY. The diagnostic value of pedobarography. Orthopedics. 2014 Dec;37(12):e1063-7. doi: 10.3928/01477447-20141124-52.
PubMed 25437079
Bakker K, Apelqvist J, Lipsky BA, Van Netten JJ; International Working Group on the Diabetic Foot. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:2-6. doi: 10.1002/dmrr.2694.
PubMed 26409930
Crawford F, Cezard G, Chappell FM, Murray GD, Price JF, Sheikh A, Simpson CR, Stansby GP, Young MJ. A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS). Health Technol Assess. 2015 Jul;19(57):1-210. doi: 10.3310/hta19570.
PubMed 26211920
Inlow S. The 60-second Foot Exam for People with Diabetes. Wound Care Can2004;2:10-11
Carreau L, Niezgoda H, LeBlond S, Trainor A, Orsted H, Woodbury MG. A prospective, descriptive study to assess the reliability and usability of a rapid foot screen for patients with diabetes mellitus in a complex continuing care setting. Ostomy Wound Manage. 2013 Jan;59(1):28-34.
PubMed 23308404
Tuna H, Birtane M, Güldiken S et al. The effect of disease duration on foot plantar pressure values in patients with type 2 diabetes mellitus. Turk J Phys Med Rehab2014;60:231-235
Lazaro-Martinez JL, Aragon-Sanchez FJ, Beneit-Montesinos JV, Gonzalez-Jurado MA, Garcia Morales E, Martinez Hernandez D. Foot biomechanics in patients with diabetes mellitus: doubts regarding the relationship between neuropathy, foot motion, and deformities. J Am Podiatr Med Assoc. 2011 May-Jun;101(3):208-14. doi: 10.7547/1010208.
PubMed 21622632
Perell KL, Merrill V, Nouvong A. Location of plantar ulcerations in diabetic patients referred to a Department of Veterans Affairs podiatry clinic. J Rehabil Res Dev. 2006 Jul-Aug;43(4):421-6. doi: 10.1682/jrrd.2005.10.0157.
PubMed 17123181
Ledoux WR, Shofer JB, Cowley MS, Ahroni JH, Cohen V, Boyko EJ. Diabetic foot ulcer incidence in relation to plantar pressure magnitude and measurement location. J Diabetes Complications. 2013 Nov-Dec;27(6):621-6. doi: 10.1016/j.jdiacomp.2013.07.004. Epub 2013 Sep 4.
PubMed 24012295

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Foot Injuries - Abnormal Distribution Patterns of Plantar Pressure in Patients With Diabetes and Its Connection to Peripheral Neuropathy, Gender, Age and BMI
ClinicalTrials.gov ID: NCT03426566
Acronym / sponsor ID: ST 690
Conditions: Diabetes Complications
Keywords: diabetic foot, pedobarography, diabetic neuropathy, plantar pressure
Study type: Observational
Recruitment status: Completed
Enrolment: 974 participants (actual)
Lead sponsor: Wroclaw Medical UniversityUniversity, hospital or other
Study start: Sep 2012 (actual)
Primary completion: Dec 2012 (actual)
Study completion: Jan 2014 (actual)
First posted: 8 Feb 2018 (actual)
Results: Posted 17 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The abnormal plantar pressure distribution (APD) plays a key role in the formation of plantar calluses which are responsible for diabetic foot ulcer.

The knowledge of APD is necessary to plan proper prevention in the group of patients with diabetes mellitus (DM).

Study design

Observational model: Other
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
patients with diabetes	–	Other: retrospective observational study with no interventionData from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Wroclaw (where the Diabetic Foot Centre exists) citizens who came spontaneously to be examined despite the absence of diabetic foot signs or symptoms

Key inclusion criteria (3 listed)

subjects with diabetes mellitus diagnosis
citizens
no previous foot ulceration and/or foot surgery

Key exclusion criteria (1 listed)

previous foot ulceration and/or foot surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
retrospective observational study with no interventionno intervention	Other	patients with diabetes

Primary outcome

Abnormal Plantar Pressure Distribution
Time frame: 1 visit
static pedobarographic test with semi-quantitative assessment: number of the patients with abnormal plantar pressure location based on a semi-quantitative method, as static barefoot pedobarographic records with colourful print analysis. The intensity of colour was proportional to the pressure received. Warm colours indicated the greatest pressure, while cold colours indicated the least plantar pressure (starting with red, then yellow, green, and blue)

2 secondary outcomes

Number of Participants With Positive Test for Neuropathy
Time frame: 1 visit
BMI
Time frame: 1 visit

Results and safety

Results posted to the registry on 17 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Diabetes	974	974

Primary outcome: Abnormal Plantar Pressure Distribution

Time frame: 1 visit. Count of participants. Unit: Participants

Measure	Patients With Diabetes n = 974
patients without APD	80
patients with APD	894

Population analysed: Patients with diabetes mellitus but without active or past foot ulcer or surgical procedure within the feet. Abnormal plantar pressure distribution (APD) - means number of participants with symmetrical abnormal pressure distribution; No APD- without such kind a distribution.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not applicable- observational, retrospective study with medical-records analysis.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Diabetes	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Lack of the influence of a type and duration of diabetes mellitus.The neuropathy evaluation based on local recommendations. The semi-quantitative analysis of the pressure map; the retrospective nature of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 6839919Boulton AJ, Hardisty CA, Betts RP, Franks CI, Worth RC, Ward JD, Duckworth T. Dynamic foot pressure and other studies as diagnostic and management aids in diabetic neuropathy. Diabetes Care. 1983 Jan-Feb;6(1):26-33. doi: 10.2337/diacare.6.1.26.
Background: PubMed 2956023Boulton AJ, Betts RP, Franks CI, Newrick PG, Ward JD, Duckworth T. Abnormalities of foot pressure in early diabetic neuropathy. Diabet Med. 1987 May-Jun;4(3):225-8. doi: 10.1111/j.1464-5491.1987.tb00867.x.
Background: PubMed 3968150Duckworth T, Boulton AJ, Betts RP, Franks CI, Ward JD. Plantar pressure measurements and the prevention of ulceration in the diabetic foot. J Bone Joint Surg Br. 1985 Jan;67(1):79-85. doi: 10.1302/0301-620X.67B1.3968150.
BackgroundRich J, Veves A. Forefoot and rearfoot plantar pressures in diabetic patients: correlation to foot ulceration. Wounds2000;12:82-87
Background: PubMed 9773736Frykberg RG, Lavery LA, Pham H, Harvey C, Harkless L, Veves A. Role of neuropathy and high foot pressures in diabetic foot ulceration. Diabetes Care. 1998 Oct;21(10):1714-9. doi: 10.2337/diacare.21.10.1714.
Background: PubMed 22271736Bakker K, Schaper NC; International Working Group on Diabetic Foot Editorial Board. The development of global consensus guidelines on the management and prevention of the diabetic foot 2011. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:116-8. doi: 10.1002/dmrr.2254.
Background: PubMed 25437079Choi YR, Lee HS, Kim DE, Lee DH, Kim JM, Ahn JY. The diagnostic value of pedobarography. Orthopedics. 2014 Dec;37(12):e1063-7. doi: 10.3928/01477447-20141124-52.
Background: PubMed 26409930Bakker K, Apelqvist J, Lipsky BA, Van Netten JJ; International Working Group on the Diabetic Foot. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:2-6. doi: 10.1002/dmrr.2694.
Background: PubMed 26211920Crawford F, Cezard G, Chappell FM, Murray GD, Price JF, Sheikh A, Simpson CR, Stansby GP, Young MJ. A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS). Health Technol Assess. 2015 Jul;19(57):1-210. doi: 10.3310/hta19570.
BackgroundInlow S. The 60-second Foot Exam for People with Diabetes. Wound Care Can2004;2:10-11
Background: PubMed 23308404Carreau L, Niezgoda H, LeBlond S, Trainor A, Orsted H, Woodbury MG. A prospective, descriptive study to assess the reliability and usability of a rapid foot screen for patients with diabetes mellitus in a complex continuing care setting. Ostomy Wound Manage. 2013 Jan;59(1):28-34.
BackgroundTuna H, Birtane M, Güldiken S et al. The effect of disease duration on foot plantar pressure values in patients with type 2 diabetes mellitus. Turk J Phys Med Rehab2014;60:231-235
Individual participant dataSharing planned: Yes. all collected individual participant data but without individual foot-print picture (mostly paper documentation) ; only the example of foot -print with explanation is available

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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.

Edyta Sutkowska, PhD principal investigator

Wroclaw Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Complications, run by Wroclaw Medical University at 1 site in Poland.

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 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Abnormal Plantar Pressure Distribution (time frame: 1 visit). 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 NCT03426566, which also lists 18 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 27 May 2022.