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International journal of pharmaceutical compounding

Wound Care of a
Diabetic Foot Ulcer
Tom Wynn, RPh
narrowing of the blood vessels in the feet and legs. Poor circu-lation in combination with the high-pressure areas on the bot- Chad Thompson, PharmD
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 possibleamputation if not treated.1 Thus, treatment of wounds in the Introduction
patient with diabetes must address both rapid granulation and It has been clearly demonstrated that wound care is one of increased circulation. Circulation can be maintained using a the foremost concerns of patients with diabetes. Poor wound topical nifedipine preparation.14 In addition, the use of pen- care can lead to the loss of toes, feet, fingers and, in some cas- toxifylline enhances vascular permeability, which increases cir- es, a limb.1 A variety of therapies exist to help ensure the culation and increases penetration of medication and nutrients proper healing of a wound, to include surgeries using vascular reconstruction techniques to create new arterial pathways that Finally, maintaining proper nutrition is very important. Not can increase blood flow to the wound.2 In addition, the use of only is proper glucose control important for wound healing growth factors such as keratinocyte-2 and interleukin-6 is be- but the intake of adequate amounts of vitamins and minerals ing studied.3 These therapies appear promising but they are also plays a key role. It has been documented17 that deficien- expensive; therefore, many patients are left to use the few cies in zinc, vitamin C and other nutrients may influence commercially available topical gels such as Regranex (0.01% becaplermin) to achieve some relief.
Case Report
Case reports and articles4-15 dating back to 1989 have sug- gested alternatives to these treatments. These alternatives in- On June 23, 2003, our pharmacy consulted with a 65-year- clude compounded topical products, which can consist of old woman who had a wound on her right foot. The wound phenytoin, misoprostol, metronidazole, or some combination was located on the pad underneath the big toe. It had a large of the three, and nifedipine. These case reports tend to show callous surrounding a deep wound that was 4 cm long and 2 cm positive outcomes with the use of these products with little to wide. The patient stated that she had little success using com- no adverse effects. The effectiveness of these topically applied mercially available products for wound care over the past year.
medications can be traced to their mechanisms of action: After discussing possible alternatives with the patient and her ■ Phenytoin promotes granulation in a wound while providing physician, a decision was made to compound a wound care gel antimicrobial effects and counteracting inflammation.4 formulation for the treatment of this patient’s wound. Prior to ■ Misoprostol is a synthetic prostaglandin that accelerates the application of any gel, the foot was inspected for venous return and measurements of the wound were taken.
Metronidazole exerts an antimicrobial effect to assist in Using a formulation from the International Journal of Phar- maceutical Compounding (IJPC)8 as a guide, two preparations ■ Nifedipine blocks the calcium influx into smooth muscles, were compounded. The first was a preparation of phenytoin thereby decreasing the vascular tone, which in turn increas- 3% and misoprostol 0.0024% gel, which was used for wound healing. The patient was instructed to cover the wound twice In the treatment of a diabetic foot ulcer another problem daily with approximately 0.2 mL of this preparation. The sec- must be considered: circulation. Over time, circulation is re- ond preparation was nifedipine 10% in a Pluronic lecithin duced in the patient with diabetes due to the hardening and organogel (PLO) gel 20%. The patient was instructed to apply International Journal of Pharmaceutical Compounding 265
Week 10 – Obvious closing of skin around
Week 14 – Obvious narrowing of wound.
Week 17 – Skin completely closed and
0.6 mL twice daily around the wound and callous and up the Conclusion
foot to increase circulation to the wound area. The patient wasinstructed to continue saline rinses as before. After rinsing Wounds in patients with diabetes can be difficult to control.
with saline, the patient applied nifedipine gel to the foot. It Treatment of foot ulcers tends to follow a three-step process: was applied around the callous of the wound and up the foot to (1) removal of the callous, (2) eradication of any infection and the ankle using a finger cot, glove or sterile swab. Each appli- (3) reduction of weight-bearing forces. This specific treatment cation consisted of 0.6 to 1 mL of the nifedipine gel. Next, plan was to shrink the callous, since the wound had no appar- the phenytoin/misoprostol mixture was applied directly to the ent infection at the time. It was discovered with this patient wound. Finally, the wound was covered with sterile gauze.
that as the callous shrank the wound size almost seemed to get This process was repeated twice daily.
larger. This was most likely due to the physician cutting away After two weeks of application, noticeable progress was seen.
at the dead skin and revealing more wound underneath the cal- The callous began to shrink and the wound appeared shallow- lous. Cutting of the wound may interfere with granulation. As er. The entire foot appeared healthier, with better color and seen with this patient and other case reports,16 healing is opti- good venous return. Progress continued, and after 8 weeks the mized when minimal cutting is done. The increase of blood healing began to increase dramatically. During the next 4 flow to the wound appeared to play a large part in the success weeks the final closure of the wound occurred. Total time of of this patient’s therapy. The patient had failed on former healing of the wound was 17 weeks. Photos included with this treatments, possibly because circulation was not addressed.
article were taken on week 10, week 14 and week 17 of the 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 Case Reports: Their Impact
Lisa D. Ashworth, RPh

■ Transdermal Methimazole for the Treatment of Feline International Journal of Pharmaceutical Compounding (IJPC) ■ Flavoring Solves Compliance Problem in Pediatric One case report may not have significant impact, but when ■ Compounded PLO Successful in Early Treatment of you compile reports for 7 years, you’ve got significant data doc- umenting the validity of individualized therapy. ■ Oral Amphotericin B for the Treatment of Intestinal The International Journal of Pharmaceutical Compounding (IJPC) has compiled and centralized its case reports. These ■ Natural Progesterone Treats Infertility valuable resources of compounded therapy are now available ■ Ketoprofen 5% and Gabapentin 5% Gel for Neuropathy on IJPC’s Website ( There are more ■ Cimetidine and 2-deoxy-d-Glucose for Treatment of than 140 human case reports and 20 animal case reports. Below is a short list presenting some of the topics and case Thank you to all the pharmacists and physicians who have reports you can find on IJPC’s Website.
worked with IJPC over the years to publish this valuable data.
■ Ketoconazole 2% and Ibuprofen 2% in Dimethyl If you would like assistance with publishing case reports, Sulfoxide, USP, Topical Nail Solution for Onychomycosis please contact Lisa D. Ashworth, RPh, 972-471-2805. W O U N D C A R E
neuropathy. The headache was later determined to be possibly 8. Glasnapp A. Basics of compounding for Raynaud’s disease. IJPC 2003; aggravated or caused altogether by a change in the patient’s 9. Meece J. Five compounds for treating diabetes-related conditions. IJPC lanoxin dose; the increased neuropathy is harder to explain.
The neuropathy may have increased because the increased 10. Kincaid MR. Options in wound care. IJPC 2002; 6(2): 92-95.
blood flow in the leg had awakened the nerves, allowing the 11. Todd G, Todd L. Case report: Nifedipine in Pluronic lecithin organogel pain to be felt. However, no literature can be found to substan- improves circulation in the feet of a diabetic patient. RxTriad October 12. Blais LR, Blais B, Sundel RP. Case report: Nifedipine oral solution for the Due to the effectiveness of wound gels in healing diabetic treatment of compromised peripheral vascular circulation in a pediatric foot ulcers, it has become a promising therapeutic alternative patient. RxTriad July 2001: 1.
that we recommend to patients with refractory foot ulcers.
13. Yarzab R, Graham D. Case report: Nifedipine in PLO 40 mg/mL for gangrene of the foot. RxTriad October 2000: 2.
14. Torsiello MJ, Kopacki MH. Transdermal nifedipine for wound healing: Case reports. IJPC 2000; 4(5): 356-358.
1. Watkins PJ. ABC of diabetes. BMJ 2003; 216: 977-979.
15. Jones M. Chronic neuropathic pain: Pharmacological interventions in 2. Gibbons GW. Lower extremity bypass in patients with diabetic foot the new millennium—a theory of efficacy. IJPC 2000; 4(1): 6-15.
ulcers. Surg Clin North Am 2003; 83(3): 659-669.
16. Israel A. Topical gel for the treatment of refractory leg ulcer. IJPC 2003; 3. Bennett SP, Griffiths BDF, Schor AM et al. Growth factors in the treat- ment of diabetic foot ulcers. Br J Surg 2003; 90(2): 133-146.
17. Rojas AI, Phillips TJ. Patients with chronic leg ulcers show diminished 4. Kincaid MR. Options in wound care. IJPC 2002; 6(2): 92-95.
levels of vitamins A and E, carotenes, and zinc. Dermatol Surg 1999; 5. Talas G, Brown RA, McGrouther DA. Role of phenytoin in wound heal- ing—a wound pharmacology perspective. Biochem Pharmacol 1999;57(10): 1085-1094.
6. Anstead GM, Hart LM, Sunahara JF et al. Phenytoin in wound healing.
Address correspondence to: Tom Wynn, RPh, Tri-State Ann Pharmacother 1996; 30(7-8): 768-775.
Compounding Pharmacy, 7715 Beechmont Avenue, Cincin- 7. Rhodes RS, Heyneman CA, Culbertson VL et al. Topical phenytoin nati, OH 45255. E-mail: ■ treatment of stage II decubitus ulcers in the elderly. Ann Pharmacother2001; 35(6): 675-681.
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International Journal of Pharmaceutical Compounding 267



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