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Table 5 Screening assessments and pre-treatments

From: Beta-adrenergic antagonist for the healing of chronic diabetic foot ulcers: study protocol for a prospective, randomized, double-blinded, controlled and parallel-group study

Demographic information Gender, age, race
Medical history Medical problems, surgeries, trauma, history of previous ulcers, amputations, characteristics, and duration
Comprehensive history and physical exam Vital signs, height, weight, body mass index
General health and lifestyle Smoking history, alcohol, drug abuse
Lower extremity exam Vascular—pedal pulses, color of skin, temperature, edema. Dermatological—clinical description of the ulcer, fungal infection of skin and/or nails, skin integrity (calluses, dryness). Musculoskeletal—foot deformities such as bunion, hammertoe, bony prominence, fat pad atrophy, altered gait. Neurological—absence or presence of sensation with 5.07/10 Semmes-Weinstein monofilament, reflexes
Non-invasive vascular study Ankle–brachial systolic pressure (ABI) and toe-brachial systolic pressure (TBI). In order to meet criteria, ankle–arm index must be equal to or greater than 0.8 and less than 1.4 or a toe-arm index is equal to or greater than 0.6
Foot ulcer history Location, length of time, treatments used, pain, etiology of ulcer
Laboratory Hematology, chemistry, EKG, microbiology and pathology HbA1c, pregnancy test (for women of childbearing ages), LFT, ESR, CRP, and albumin
Radiological imaging Plain foot and/or ankle films for baseline
Health—quality of life surveys VR-36 Health Survey and the Lower Extremity Functional Scale Outcome Questionnaire
Debridement and specimen collection Sharp debridement of ulcer will be performed per standard method. A small sample will be collected for microbiology (gram stain, cultures/sensitivities, and fungal) and pathology
Photographs Before and after debridement using Silhouette Mobile™ ulcer tracing, surface area calculation
Dressings Non-adhesive dressing (Adaptic® or Mepitel®) over wound bed, covered by dry dressings
Off-loading Shoes will be given, modified offloading insert (trilaminar plastazote) as determined appropriate at the discretion of the clinician