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Table 1 Study schedule

From: Impact of omega-3 fatty acid oral therapy on healing of chronic venous leg ulcers in older adults: Study protocol for a randomized controlled single-center trial

Time point

Pre-Visit

Visit 1 (Week 0)

Visit 2

(Week 4)

Visit 3

(Week 8)

Visit 4

(Week 12)

Visit 5*

(3 mos. Post Week 12)

Enrollment

 Screening

X

     

 Informed consent

 

X

    

 Allocation

 

X

    

Interventions

 Treatment (EPA + DHA)

 

X

X

X

X

X

 Placebo (mineral oil)

 

X

X

X

X

 

Assessments

 Wound treatments

X

X

X

X

X

X

 Adherence

  

X

X

X

X

Biological measures

 Blood and wound fluid

 

X

X

X

X

X

 Fatty acids

 

X

X

X

X

X

 n-3, n-6 lipid mediators

 

X

X

X

X

X

 Cytokines

 

X

X

X

X

X

 PMN activation

 

X

X

X

X

X

 Proteases (wound fluid only)

 

X

X

X

X

X

 Wound area (if wound is present)

 

X

X

X

X

X

 Body mass index

 

X

X

X

X

X

 CEAP

 

X

X

X

X

X

 Revised VCSS (includes pain score)

 

X

X

X

X

X

Interview/self-report

 Sociodemographic Questionnaire

 

X

    

 Perceived Stress Scale

 

X

X

X

X

X

 Health history

 

X

    

 Food frequency Questionnaire

 

X

  

X

X

 VEINES-QoL/Sym Questionnaire

 

X

  

X

X

  1. Legend: X = Collected at the given time point. n-3 = Omega 3; n-6 = Omega 6; PMN = polymorphonuclear leukocytes; CEAP = Clinical, Etiologic, Anatomic, and Pathophysiologic classification; VCSS = Venous Clinical Severity Score; VEINES-QoL/Sym = VEnous Insufficiency Epidemiological and Economic Study – Quality of Life/Symptoms. *All assessments at visit 5 are for participants initially randomized to the treatment group, have healed wounds by visit 4, and are consented for the additional study. At visit 4, these participants will be re-randomized to the treatment group or placebo group and have one more study visit, 3 months following visit 4
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Trials

ISSN: 1745-6215