- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00760357
A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia
24. november 2015 opdateret af: Randall Wolcott, Southwest Regional Wound Care Center
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated.
The data that will be extracted from each chart will include patient's age, patient's gender, number of office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic administered, number of hyperbaric oxygen treatments, and if the wound healed.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Clinicians have even learned to group patients into different etiologic categories based on underlying disease such as diabetes mellitus, decubitus ulcer, surgical site infection, venous insufficiency, arterial insufficiency and others.
It seems that wounds have been grouped into these categories because of their common barriers, which should allow us more precise algorithms and may provide better outcomes.
That is diabetics tend to have the barriers of poor perfusion, endothelial cell dysfunction, white blood cell dysfunction, hyperglycemia, neuropathy and repetitive trauma.
Venous insufficiency patients tend to have perivascular cuffing and peri wound edema.
However patients with venous leg ulcers commonly have peripheral arterial disease and diabetes (3).
The point is regardless of the etiology of the wound every patient must be evaluated for all barriers on every visit.
Arbitrarily dividing chronic wounds in the etiologic categories has not significantly improved wound healing outcomes.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
190
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Texas
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Lubbock, Texas, Forenede Stater, 79410
- Southwest Regional Wound Care Center
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated.
The data that will be extracted from each chart will include patient's age, patient's gender, number of office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic administered, number of hyperbaric oxygen treatments, and if the wound healed.
Beskrivelse
Inclusion Criteria:
The inclusion criteria for the study are patients that demonstrate the following:
- A limb with a TCpO2 less than 20 with a full thickness wound.
- Initial visit from August 1, 2002 to December 31, 2005.
Exclusion Criteria:
The exclusion criteria for the study are patients that demonstrate the following:
- Partial thickness wound or no wound in limb with critical ischemia.
- A medical record that does not clearly demonstrate critical limb ischemia or does not clearly demonstrates a full thickness wound.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Retrospective Anaylsis
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated
Tidsramme: 1 year
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1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Randall D Wolcott, MD, Southwest Regional Wound Care Center
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
1. april 2007
Primær færdiggørelse (Faktiske)
1. april 2008
Studieafslutning (Faktiske)
1. april 2008
Datoer for studieregistrering
Først indsendt
24. september 2008
Først indsendt, der opfyldte QC-kriterier
25. september 2008
Først opslået (Skøn)
26. september 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 56-RW-007
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 .
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