Trial document




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  DRKS00012580

Trial Description

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Title

Prevalence of peripheral artery disease (PAD) in patients with disturbed wound healing following foot or ankle surgery

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Trial Acronym

ABI-PRIORY (ABI as a PRedictor of Impaired wound healing after ORthopaedic surgerY)

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URL of the Trial

http://N/A

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Brief Summary in Lay Language

Successful surgery requires healing of surgical wounds. In some patients wounds do not heal properly. This is a relatively common problem after foot and ankle surgery. One possible reason for disturbed wound healing is impaired blood flow to the legs and feet. However, assessment of blood flow is currently not part of the routine in the treatment of patients undergoing foot and ankle surgery. The aim of the current study is to shed light on the potential relationship between reduced blood flow to the legs due to peripheral artery disease (PAD) and the occurence of wound healing impairment. We plan to examine the blood flow to the legs using a non-invasive method (ABI) in patients that underwent foot or ankle surgery - both patients who experienced normal wound healing and patients who suffered from impaired wound healing. Our long-term goal is an improved understanding of the relationship between PAD and wound healing, potentially leading to better prophylaxis and treatment of wound healing impairment ind the future.

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Brief Summary in Scientific Language

Impaired wound healing is a relevant complication of foot and ankle surgery. Despite the similarity of predisposing factors for wound complications and peripheral artery disease (PAD) and the increasing prevalence of the latter with age, current preoperative concepts do not take this potential relationship into consideration. The current case-control study compares ankle-brachial-index (ABI) in patients after foot or ankle surgery who experienced normal wound healing with patients who suffered from a wound complication (matched for sex and age), in order to obtain the prevalence of PAD in both populations. Patients are screened retrospectively after surgery and after informed consent, a single non-invasive measurement of ABI is performed. In perspective, results from this study may improve our understanding of imparied wound healing and influence pre-operative diagnostic work-up.

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Organizational Data

  •   DRKS00012580
  •   2017/07/04
  •   [---]*
  •   yes
  •   Approved
  •   209/17 S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I70.2 -  Atherosclerosis of arteries of extremities
  •   T81.3 -  Disruption of operation wound, not elsewhere classified
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Interventions/Observational Groups

  •   Patients aged 45 and older who underwent foot or ankle surgery between 2014 and 2017 and suffered from impaired wound healing. For assessment of the prevalence of PAD one-time ABI (ankle brachial index) will be measured.
  •   Sex and Age matched control patients who underwent foot or ankle surgery between 2014 and 2017 but did not suffer from impaired wound healing. For assessment of the prevalence of PAD one-time ABI (ankle brachial index) will be measured.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Screening
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Difference in prevalence of PAD (ABI < 0.9 or >1.4) in patients with and without impaired wound healing.

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Secondary Outcome

Association of symptomatic/asymptomatic PAD with impaired wound healing, days to completed wound healing, need for repeat surgery, rehospitalization

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/07/15
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   45   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients 45 years or older, foot or ankle surgery between 2014 and 2017

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Exclusion Criteria

N/A

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Addresses

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Klinik und Poliklinik für Innere Medizin IKlinikum rechts der Isar der Technischen Universität München
    • Mr.  Dr.  Ralf  Dirschinger 
    • Ismaningerstr. 22
    • 81675  München
    • Germany
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    • Klinik und Poliklinik für Innere Medizin IKlinikum rechts der Isar der Technischen Universität München
    • Mr.  Dr.  Ralf  Dirschinger 
    • Ismaningerstr. 22
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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Status

  •   Enrolling by invitation
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.