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visit us at www.dermagraft.com Healing of Chronic Foot Ulcers in Diabetic Patients Treated with a Human Fibroblast-Derived Dermis The Journal of Foot & Ankle Surgery, Volume 41, Number 5, 2002 Jason R. Hanft, DPM Maria S. Surprenant, DPM • Healed Dermagraft treated patients achieved wound closure significantly faster than control patients (P=0.004) • Dermagraft treated patients showed a statistically significant higher percentage of wound closure by week 12 than did control patients (P=0.002) • The incidence of infection was lower in the Dermagraft treatment group than in the control group • Patients foot ulcers were located on the platar surface of the forefoot or heel • Although off-loading was part of the treatment regimen, patients reported being ambulatory up to 8 hours a day key points 14.29 71.43 100 90 80 70 60 50 40 30 20 10 0 Percent of Patients Healed Control Dermagraft P=.003 percentage of patients healed The y-axis consists of the percent of patients healed (complete wound closure) by week 12. The x-axis consists of treatment groups (control vs. HFDD). The gray bar represents the Control treatment group. The red bar represents the Dermagraft treatment group. A prospective, multicenter, randomized, controlled 12-week study was undertaken to evaluate the effectiveness of a human fibroblast-derived dermis for treating foot ulcers in the diabetic patient. This report summarizes the findings of a prospective, single-blind, randomized, controlled trial at one of the centers. The study population was comprised of 28 patients with chronic ulcers (>6 weeks’ duration at time of screening). Following a 2-week screening period, patients were randomized to either human fibroblast-derived dermal substitute (HFDS) (Dermagraft) plus saline-moistened gauze or to the control group (CT) of saline- moistened gauze alone. Effectiveness end points were: (1) wound closure by week 12; (2) time to wound closure; and (3) percent wound closure by week 12. Safety was assessed by review of adverse events and laboratory findings. Patients randomized to HFDS received an application at day 0 and up to seven additional treatments over the 12-week study. All patients in each group received shoes with custom-molded inserts and were seen weekly. By week 12, significantly more chronic ulcers healed in the HFDS groups than in the CT group (71.4% versus 14.3%, P=0.003). Healed HFDS patients achieved wound closure significantly faster than CT patients (P=0.004). Patients treated with HFDS showed a statistically significant higher percent of wound closure by week 12 than did CT patients (P=0.002). The percent of patients who experienced an infection involving their study wound was less in the HFDS group than in the CT group. To access the safety and effectiveness of the Dermagraft product in the treatment of plantar diabetic foot ulcers as compared with conventional therapy alone. Patients who were treated with HFDS showed a significantly higher percent of wound closure by week 12 than did control patients, 71.4% and 14.3%, respectively. Healed HFDS patients achieved wound closure significantly faster than control patients. The results of this study suggest that Dermagraft is a safe and effective treatment for diabetic foot ulcers that are greater than 6 weeks’ duration. abstract research design and methods results objective conclusions
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visit us at www.dermagraft.com
Healing of Chronic Foot Ulcers in Diabetic Patients Treated with a Human Fibroblast-Derived DermisThe Journal of Foot & Ankle Surgery, Volume 41, Number 5, 2002
Jason R. Hanft, DPMMaria S. Surprenant, DPM
•HealedDermagrafttreatedpatientsachievedwoundclosuresignificantlyfasterthancontrolpatients (P=0.004)
•Dermagrafttreatedpatientsshowedastatisticallysignificanthigherpercentageofwoundclosureby week 12 than did control patients (P=0.002)
•TheincidenceofinfectionwaslowerintheDermagrafttreatmentgroupthaninthecontrolgroup
•Patientsfootulcerswerelocatedontheplatarsurfaceoftheforefootorheel
•Althoughoff-loadingwaspartofthetreatmentregimen,patientsreportedbeingambulatoryupto 8 hours a day
key points
14.29
71.43
100
90
80
70
60
50
40
30
20
10
0
Per
cent
of Pat
ients
Hea
led
Control Dermagraft P=.003
percentage of patients healed
The y-axis consists of the percent of patients healed (complete wound closure) by week 12. The x-axis consists of treatment groups (control vs. HFDD). The gray bar represents the Control treatment group. The red bar represents the Dermagraft treatment group.
A prospective, multicenter, randomized, controlled
12-week study was undertaken to evaluate the
effectiveness of a human fibroblast-derived dermis
for treating foot ulcers in the diabetic patient. This
report summarizes the findings of a prospective,
single-blind, randomized, controlled
trial at one of the centers.
The study population was comprised of 28
patients with chronic ulcers (>6 weeks’ duration
at time of screening). Following a 2-week
screening period, patients were randomized to
either human fibroblast-derived dermal substitute
(HFDS) (Dermagraft) plus saline-moistened
gauze or to the control group (CT) of saline-
moistened gauze alone. Effectiveness end points
were: (1) wound closure by week 12; (2) time
to wound closure; and (3) percent wound closure
by week 12. Safety was assessed by review of
adverse events and laboratory findings. Patients
randomized to HFDS received an application at
day 0 and up to seven additional treatments over
the 12-week study. All patients in each group
received shoes with custom-molded inserts and
were seen weekly.
By week 12, significantly more chronic ulcers
healed in the HFDS groups than in the CT group
(71.4% versus 14.3%, P=0.003). Healed HFDS
patients achieved wound closure significantly
faster than CT patients (P=0.004). Patients
treated with HFDS showed a statistically significant
higher percent of wound closure by week 12
than did CT patients (P=0.002). The percent of
patients who experienced an infection involving
their study wound was less in the HFDS group
than in the CT group. To access the safety and effectiveness of the
Dermagraft product in the treatment of plantar
diabetic foot ulcers as compared with conventional
therapy alone.
Patients who were treated with HFDS showed
a significantly higher percent of wound closure
by week 12 than did control patients, 71.4%
and 14.3%, respectively. Healed HFDS patients
achieved wound closure significantly faster than
control patients. The results of this study suggest
that Dermagraft is a safe and effective treatment
for diabetic foot ulcers that are greater than 6
weeks’ duration.
abstract
research design and methods
results
objective
conclusions
