For those too lazy to look like the chosen one, here you go.
Time to ulcer closure [ Time Frame: Up to 6 months ]
The time period for the index ulcer to close
Ankle Brachial Index (ABI ) and Toe-Brachial Index (TBI) [ Time Frame: Up to 6 months ]
ABI and TBI will be calculated by dividing the systolic blood pressure at the ankle or toe by the systolic blood pressures (Doppler technique) in the arm
50% Closure of Index Ulcer [ Time Frame: Up to 24 months ]
The proportion of subjects with at least 50% closure of the index ulcer
Transcutaneous oxygen [ Time Frame: Up to 6 months ]
Transcutaneous oxygen measurements determine the oxygen level in tissue below the skin
Time to amputation, ulcer opening closing, gangrene and infection [ Time Frame: Up to 24 months ]
Time to major amputation (above the ankle) of treated leg, minor amputations, to re-opening of ulcer, time to doubling / halving of index ulcer total surface area from baseline, de novo gangrene and foot wound infection
Wagner Grading Scale [ Time Frame: Up to 24 months ]
The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene by using the following grades: grade 0 (pre-or postulcerative lesion), grade 1 (partial/full thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene), and grade 5 (whole foot gangrene).
Rutherford Criteria [ Time Frame: Up to 6 months ]
The Rutherford classification is a clinical staging system for describing peripheral arterial disease.
36-item Short Form Health Survey (SF-36) [ Time Frame: Up to 6 months ]
A validated measurement of health related quality of life
Diabetic Foot Ulcer Scale Short Form (DFS-SF) index ulcer [ Time Frame: Up to 6 months ]
A measurement of the impact of diabetic foot ulcer on a patient's quality of life.
Patient Global Impression of Change in Neuropathy (PGICN) [ Time Frame: Up to 24 months ]
Assessment of changes in neuropathy over time
European Quality of Life: EuroQOL-5D- health utility index assessment (EQ-5D) [ Time Frame: Up to 6 months ]
A standardized instrument used as a measure of health outcome
Number of all ulcers [ Time Frame: Up to 24 months ]
The total number of ulcers
Leg rest pain score [ Time Frame: Up to 24 months ]
A visual analog scale (VAS) graded from 0 (pain free) to Grade 10 (maximum pain)
