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The primary end point was decrease in ulcer size.
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The differences in ulcer size reduction between the two groups were compared using the Mann-Whitney test.
To compute changes in ulcer size, ulcers were measured at baseline and, if the ulcer was not healed, at each follow-up visit.
We measured time to healing of the reference ulcer, health related quality of life, proportion of participants with ulcers healed at 12 months, percentage and absolute change in ulcer size, adverse events, and cost of treatments.
A difference in ulcer size was detected when comparing DFUs that did not heal with DFUs that did heal.
In a multicenter study that we participated in [ 16], intramuscular grafting in patients with CLI improved visual analogue scale, decreased ulcer size, and increased walk distance in both PAD and Buerger's disease groups and particularly visual analogue scale was confirmed to continue until at least 2 years after.
The results indicated that the highest decrease in ulcer area was observed in group treated with microemulsion containing TGF-α plus aprotinin (TA-ME).
Another study comparing patients with chronic non-healing VLU (mean duration of ulceration upon entering study was 23.9 months and median ulcers size of 13.5 cm) treated with standard compression therapy or Apligraf reported a 0.72 cm increase in mean ulcer size per week in the control group, while the Apligraf-treated group had an average decrease of 2.37 cm per week.
Those cells were confirmed to be effective to decrease rest pain and ulcer size, but its effect was not fully satisfied.
In a more recent study, complete closure incidence observed in GAM501 (ulcer size: 3.1 ± 1.7 cm) and formulated collagen alone (ulcer size: 2.9 ± 1.1 cm) was not statistically significant [ 8].
A reduction in ischemic ulcers accompanied by a decrease in the size of ulcers was observed in 9 of 10 patients (90%) at 2 years.
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