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Table 1 Schedule of study assessments and evaluations

From: A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol

   

Treatment Phase

Follow-up Phase

Long-Term Follow-up

Clinical Assessments, Testing and Investigations

Screening and Randomization

Baseline

Weeks 1 to 6

End of Treatment

Weeks 6 to 12

End of Follow-up

Week 30

Week 52

Suitability for HBOT

X

       

Electrocardiogram

O

       

Pulmonary Function Testing

O

X

      

Audiogram

O

       

Chest X-ray

O

       

X-ray of affected limb

O

X

      

Nuclear bone scan

O

       

Vascular Exam

X

O

O

O

O

X

  

History & Physical

 

X

      

Demographics

 

X

      

Treatment Details

 

X

X

     

Wound Classifications (Wagner, Bates)

X

X

X

 

X

   

Wound Measurements

 

X

X

 

X

   

Wound Characteristics

 

X

X

 

X

   

Digital Photograph of wound

 

X

X

 

X

   

Dressing Changes

X

X

X

 

O

O

  

Concomitant Meds

 

X

X

 

X

   

Assess for Infection

X

X

X

 

X

   

Mobility Status

 

X

X

 

X

   

Adverse Events

 

X

X

 

X

 

X

X

Outcome Assessment

X

X

X

 

X

   

Unblinding

 

O

O

O

O

O

  

Laboratories

X

X

 

X

 

X

  

Resource Utilization

 

X

X

 

X

 

X

X

Quality of Life:

        

SF-36

 

X

 

X

 

X

  

EQ-5D

 

X

 

X

 

X

X

X

DFS-SF

 

X

 

X

 

X

  
  1. x = required o = optional
  2. SF-36: Short-Form 36; EQ-5D: EuroQoL 5D; DFS-SF: Diabetic Foot Ulcer Scale - Short Form
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Trials

ISSN: 1745-6215