HEAL-IT

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HEAL-IT
Bauer Sumpio Yale University Suephy C. Chen,
William S. Weintraub Emory University Sponsor
Otsuka America
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Facts of The Trial William S. Weintraub,
MD Professor of Medicine Emory University Director
, Emory Center for Outcomes Research
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Specific Aim To evaluate the ability of
cilostazol (Pletal) to improve wound healing of
ischemic foot ulcers in combination with standard
local wound care compared to local wound care
alone.
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• Background
• Foot ulcer prevalence- 1-2 in over-50 age group
• PVD accounts for up to 2/3 of the etiology
• Cilostazol originally utilized for healing
  ischemic ulcers in Japan but only anecdotal
  reports
• Cilostazol approved by FDA for claudication 1999

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Hypothesis Cilostazol will improve wound healing
in ischemic leg ulcers in combination with
standard local wound care compared to local wound
care alone.
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Primary Endpoint Mean rate of healing of target
ulcer ( per month, where a month is 30 days)
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• Secondary Endpoints
• Change in target ulcer area (cm2)
• Target ulcer completely healed (yes/no)
• Time to complete healing of target ulcer
• Percent healing of target ulcer
• Number of ulcers on leg where target ulcer
  resides
• Quality of life improvement
• Cost

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• Design
• Multicenter, randomized double blind clinical
  trial
• 300 patients at 20 sites (15-20 per site)

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• Study Drug Handling
• Be sure that patient number on study drug and
  patient number on CRF match. Be sure to go in
  order, i.e. do not skip numbers.
• Patients will be given a full 6-month supply of
  study drug in a kit containing pill bottles and a
  daily dispenser
• Study drug is in bottles containing 132 tablets.
• At three month and six month visits patients
  should bring their kit and all pill bottles,
  empty, partially full and full for pill count.
• Patients be resupplied if they lose their
  original supply.
• All remaining drug supplies should be returned to
  ECOR at the end of the study

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• Follow-up
• Clinical follow-up every month
• Place a dated, signed copy of follow-ups in the
  medical record
• Ulcer counts, target ulcer border tracing and
  digital photographs will be done at each visit
• Quality of life assessments done at baseline and
  at 6 months

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• Site monitoring
• All sites will be monitored via CRF photos.
• Sites will be asked for copies of source
  documentation after the first 2 patients are
  enrolled, or 1 month after initiation of the
  trial, whichever occurs first.

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• Case Report Forms
• Case report forms is made up in Teleform?
• Copy pages and save copy.
• Send originals to ECOR every month
• FAX randomization form to ECOR at randomization
  404-727-6495
• FAX SAE forms to ECOR after event

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• Communications
• Reporting will include
• DCFs
• Summary reporting
• Newsletter
• Website

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HEAL-IT website http//www.emory.edu/WHSC/CARDIOL
OGY/CVEC/HealIT Login healit Password
woundhealing
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Patient Demographics
Variable Mean (SD, N)
Age (years) 70 (13, 22)
Height (cm) 169.6 (19.8, 21)
Weight (kg) 81.2 (21.2, 21)
Toe Pressure (mmHg) 31.5 (7.3, 8)
Chest TCPO2 48.8 (8.8, 14)
Dorsum TCPO2 29.7 (7.0, 15)
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Patient Demographics
Variable N ()
Male Gender 16 (73)
Caucasian Race 17 (77)
Diabetes 15 (68)
Hypertension 14 (64)
Renal Insufficiency 3 (14)
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Patient Demographics
Variable N ()
Cardiac Disease 10 (45)
CABG 3 (30)
MI 7 (70)
PCI 3 (30)
CABG, MI, and PCI denotes those patients who had
cardiac disease and CABG, MI, and/or PCI.
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Patient Demographics
Variable N ()
Cerebrovascular Disease 4 (18)
Prior Stroke 3 (75)
Prior Stroke denotes those patients with
cerebrovascular disease who had a prior stroke.
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Ulcer Location
Location N
Digit 12
MTP Joint 1
Mid-Plantar Arch 3
Metatarsal Head 4
Other Location 5
Multiple Locations are possible. Example
Metatarsal Head and Digit.
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Ulcer Location
Location N ()
Medial Aspect 13 (59)
Right Side 11 (50)
1 Edema 4 (19)
Number of Ulcers 1 2 3 13 (59) 8 (36) 1 (5)
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So where are we? 23 patients randomized Sample
size 300 We are 8 of the way there To finish
enrollment by end of October we need 21 a week Or
about one patient per site per week
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Can we have a meaningful trial with fewer
patients? Yes (so dont give up) However, the
more patients we randomize, the stronger the study
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Why this trial is important Arterial ulcers are
a serious problem in patients with PVD Anecdotal
evidence support the use of Pletal for wound
healing Pletal will not become routine for wound
healing without this trial If positive, HEAL-IT
will offer patients a beneficial new therapy
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What do we need to do? Randomize, Randomize,
Randomize