Table 5 Screening assessments and pre-treatments

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