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Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures (DFE)

8. november 2021 opdateret af: Temple University
The purpose of this study is to examine the effectiveness of a novel patient education strategy, compared to a standard diabetic foot education. The proposed diabetic foot care education uses personal computer-animated plantar pressure data to educate patients on why and how they should care for their feet.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Using block randomization, subjects with diabetes were assigned to either the standard or the enhanced education group. The effectiveness of enhanced education was evaluated as measured by foot care behavior score, patient's interpretation of neuropathy scores, and the incidence of diabetic foot complications over a course of 1-year.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

99

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Gait Study Center; Temple University School of Podiatric Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female between the ages of 21 and 75 years (inclusive)
  • Documented type 1 or type 2 diabetes mellitus
  • Demonstrates peripheral neuropathy (defined as vibration perception threshold (VPT) ≥ 25 volts at the hallux, as quantified by a BioThesiometer, or unable to perceive a 10 gram Semmes-Weinstein monofilament in one four sites on the feet)
  • Able to walk independently without the use of walking aids (cane, crutches, or walker)
  • Able to speak and understand English
  • Able to understand the information in the informed consent form and willing and able to sign the consent form

Exclusion Criteria:

  • Amputation of either foot proximal to midfoot
  • Presence of cutaneous ulceration in the lower extremity
  • History of or active Charcot neuroarthropathy of either foot
  • Severe peripheral vascular disease (ie. ischemic rest pain, 2-block claudication or gangrene)
  • End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease
  • Pregnant or nursing
  • Life expectancy < 12 months
  • Not willing or able to make the required follow-up visits
  • Insufficient (corrected) vision to complete the questionnaires

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: enhanced foot care education
In addition to the standard diabetic foot self-care instruction, the importance of daily foot self-care was reinforced at baseline by viewing personal barefoot plantar pressure in gait
Adfærdsmæssigt: Enhanced foot care education
In addition to the standard foot care education, personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated once at baseline visit. The demonstration includes diabetic foot education on the topic of diabetic neuropathy and how barefoot walking can lead to skin breakdown and ulcer formation, which can lead to infection and eventual amputation. The education also highlights the high plantar pressures experienced by individuals while barefoot versus in-shoe and how proper footwear is necessary in conjunction with other standard self-foot care measures to prevent injury and complications.
Aktiv komparator: Standard Foot Care Education
Reviewed the standard diabetic foot self-care instructions, including daily foot inspection and proper footwear at all times.
Adfærdsmæssigt: Standard Foot Care Education
At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed and dispensed. "Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails." "Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Foot Care Behavior Score
Tidsramme: baseline, 1, 3,6,9 and 12 months
Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily
baseline, 1, 3,6,9 and 12 months
Patient Interpretation of Neuropathy (PIN) Questionnaire
Tidsramme: Baseline, months 1, 3, 6, and 12.
Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation)
Baseline, months 1, 3, 6, and 12.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Foot Complications
Tidsramme: 1 year
Number of participants with foot complications
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Temple University

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Jinsup Song, DPM, PhD, Temple University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. maj 2008

Primær færdiggørelse (Faktiske)

7. september 2011

Studieafslutning (Faktiske)

14. marts 2012

Datoer for studieregistrering

Først indsendt

4. april 2013

Først indsendt, der opfyldte QC-kriterier

9. september 2013

Først opslået (Skøn)

13. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11447
  • K23DK081021 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus

Kliniske forsøg med Enhanced foot care education

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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