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Current View
Case Report:
International Journal
Pharmaceutical Compounding
Vol. 8 No. 4 July/August 2004
It has been clearly demonstrated that wound care is one of
the foremost concerns of patients with diabetes. Poor wound
care can lead to the loss of toes, feet, fingers and, in some cas-
es, a limb.
A variety of therapies exist to help ensure the
proper healing of a wound, to include surgeries using vascular
reconstruction techniques to create new arterial pathways that
can increase blood flow to the wound.
In addition, the use of
growth factors such as keratinocyte-2 and interleukin-6 is be-
ing studied.
These therapies appear promising but they are
expensive; therefore, many patients are left to use the few
commercially available topical gels such as Regranex (0.01%
becaplermin) to achieve some relief.
Case reports and articles
dating back to 1989 have sug-
gested alternatives to these treatments. These alternatives in-
clude compounded topical products, which can consist of
phenytoin, misoprostol, metronidazole, or some combination
of the three, and nifedipine. These case reports tend to show
positive outcomes with the use of these products with little to
no adverse effects. The effectiveness of these topically applied
medications can be traced to their mechanisms of action:
promotes granulation in a wound while providing
antimicrobial effects and counteracting inflammation.
is a synthetic prostaglandin that accelerates
wound healing.
exerts an antimicrobial effect to assist in
wound care.
blocks the calcium influx into smooth muscles,
thereby decreasing the vascular tone, which in turn increas-
es blood flow.
In the treatment of a diabetic foot ulcer another problem
must be considered: circulation. Over time, circulation is re-
duced in the patient with diabetes due to the hardening and
narrowing of the blood vessels in the feet and legs. Poor circu-
lation in combination with the high-pressure areas on the bot-
tom of the foot can lead to callous formation in the patient
who has diabetes. If not addressed, the callous can lead to an
ulcer. The final stage can be gangrene of the toes and possible
amputation if not treated.
Thus, treatment of wounds in the
patient with diabetes must address both rapid granulation and
increased circulation. Circulation can be maintained using a
topical nifedipine preparation.
In addition, the use of pen-
toxifylline enhances vascular permeability, which increases cir-
culation and increases penetration of medication and nutrients
to the wound.
Finally, maintaining proper nutrition is very important. Not
only is proper glucose control important for wound healing
but the intake of adequate amounts of vitamins and minerals
also plays a key role. It has been documented
that deficien-
cies in zinc, vitamin C and other nutrients may influence
wound-healing rates.
Case Report
On June 23, 2003, our pharmacy consulted with a 65-year-
old woman who had a wound on her right foot. The wound
was located on the pad underneath the big toe. It had a large
callous surrounding a deep wound that was 4 cm long and 2 cm
wide. The patient stated that she had little success using com-
mercially available products for wound care over the past year.
After discussing possible alternatives with the patient and her
physician, a decision was made to compound a wound care gel
formulation for the treatment of this patient’s wound. Prior to
the application of any gel, the foot was inspected for venous
return and measurements of the wound were taken.
Using a formulation from the
International Journal of Phar-
maceutical Compounding
as a guide, two preparations
were compounded. The first was a preparation of phenytoin
3% and misoprostol 0.0024% gel, which was used for wound
healing. The patient was instructed to cover the wound twice
daily with approximately 0.2 mL of this preparation. The sec-
ond preparation was nifedipine 10% in a Pluronic lecithin
organogel (PLO) gel 20%. The patient was instructed to apply
Wound Care of a
Diabetic Foot Ulcer
om Wynn, RPh
Chad Thompson, PharmD
ri-State Compounding Pharmacy
Cincinnati, Ohio
International Journal
Pharmaceutical Compounding
Vol. 8 No. 4 July/August 2004
0.6 mL twice daily around the wound and callous and up the
foot to increase circulation to the wound area. The patient was
instructed to continue saline rinses as before. After rinsing
with saline, the patient applied nifedipine gel to the foot. It
was applied around the callous of the wound and up the foot to
the ankle using a finger cot, glove or sterile swab. Each appli-
cation consisted of 0.6 to 1 mL of the nifedipine gel. Next,
the phenytoin/misoprostol mixture was applied directly to the
wound. Finally, the wound was covered with sterile gauze.
This process was repeated twice daily.
After two weeks of application, noticeable progress was seen.
The callous began to shrink and the wound appeared shallow-
er. The entire foot appeared healthier, with better color and
good venous return. Progress continued, and after 8 weeks the
healing began to increase dramatically. During the next 4
weeks the final closure of the wound occurred. Total time of
healing of the wound was 17 weeks. Photos included with this
article were taken on week 10, week 14 and week 17 of the
treatment period.
ounds in patients with diabetes can be difficult to control.
eatment of foot ulcers tends to follow a three-step process:
(1) removal of the callous, (2) eradication of any infection and
(3) reduction of weight-bearing forces. This specific treatment
plan was to shrink the callous, since the wound had no appar-
ent infection at the time. It was discovered with this patient
that as the callous shrank the wound size almost seemed to get
larger. This was most likely due to the physician cutting away
at the dead skin and revealing more wound underneath the cal-
lous. Cutting of the wound may interfere with granulation. As
seen with this patient and other case reports,
healing is opti-
mized when minimal cutting is done. The increase of blood
flow to the wound appeared to play a large part in the success
of this patient’s therapy. The patient had failed on former
treatments, possibly because circulation was not addressed.
Once circulation was returned to the foot and the callous was
under control, the wound began to heal rapidly.
The only adverse effects reported during the course of
therapy were a slight headache and an increase in peripheral
Lisa D. Ashworth, RPh
International Journal of Pharmaceutical Compounding
IJPC RxTriad
Edmond, Oklahoma
One case report may not have significant impact, but when
you compile reports for 7 years, you’ve got significant data doc-
umenting the validity of individualized therapy.
The International Journal of Pharmaceutical Compounding
) has compiled and centralized its case reports. These
valuable resources of compounded therapy are now available
on IJPC’s Website (www.ijpc.com/casereports). There are more
than 140 human case reports and 20 animal case reports.
Below is a short list presenting some of the topics and case
reports you can find on IJPC’s Website.
Ketoconazole 2% and Ibuprofen 2% in Dimethyl
Sulfoxide, USP, Topical Nail Solution for Onychomycosis
ransdermal Methimazole for the Treatment of Feline
Flavoring Solves Compliance Problem in Pediatric
Compounded PLO Successful in Early Treatment of
Herpes Zoster (Shingles)
Oral Amphotericin B for the Treatment of Intestinal
Fungal Infection
Natural Progesterone Treats Infertility
Ketoprofen 5% and Gabapentin 5% Gel for Neuropathy
Cimetidine and 2-deoxy-d-Glucose for Treatment of
Plantar Warts
Thank you to all the pharmacists and physicians who have
worked with
over the years to publish this valuable data.
If you would like assistance with publishing case reports,
please contact Lisa D. Ashworth, RPh, 972-471-2805. E-mail:
Case Reports: Their Impact
eek 10
– Obvious closing of skin around
eek 14
– Obvious narrowing of wound.
eek 17
– Skin completely closed and
obvious healing of wound.