Diabetic foot ulcers are becoming an increasing concern, with more then 15% of people diagnosed with diabeties experiencing a foot ulcer at some point of their illness (PCCA, 2000), with 14 to 24% of these patients needing a lower extremity amputation (PCCA, 2000; Wynn and Thompson, 2003). Poor circulation is a contributing factor in the formation and reduced healing time of foot ulcers in diabetic patients, due to the hardening and narrowing of the blood vessels in the lower extremities (Ebadi et al., 2003).Recent Studies have suggested that a topical preparation of the calcium channel blocker Nifedipine, may play an important role in the healing process. The mechanism of action of Nifedipine works by blocking the influx of calcium into smooth muscle, increasing vascular tone and blood flow (Wynn and Thompson, 2003). A double-blind placebo controlled trial conducted by Nikolova in 1995, using a 10mg/mL topical solution of Nifedipine demonstrated a favourable result in the treatment of hypertensive venous leg ulcers, by decreasing the healing time of the wound (Nikolova, 1995). This result has also been shown in two more recent trials, in which topical preparations of 2% to 10% of Nifedipine decreased healing time (wound size) from four to five months to six to eight weeks (Smith, 2010; Torsiello and Kopacki, 2004; Wynn and Thompson, 2003) with little to no adverse side effects. This effect may be due to a large to improvement of the subcutaneous circulation of the lower legs (Nikolova, 1995).
The aim of this trial is to investigate if topical Nifedipine may play a role in the healing of diabetic ulcers, which may decrease the risk of infection and lower extremity amputations.
This trail is available to 20 diabetic patients for free for up to six months. The patients must be diabetic with a foot ulcer in which all other methods of treatments have failed and amputation is being considered.
The patient must have their blood glucose and blood pressure under control and be willing to be monitored and report these levels throughout the trial.
The patient must be excluded from the trial if they at anytime:-
Experience any weeping, infection or excessive pain of the wound
Already/Start taking Nifedipine
Already taking more then 10+ medications
Already or planning on becoming pregnant or lactating
Although gels are preferred over oral administration due to the lesser incidence of side effects, some may include, but are not limited to:-
Heartburn / Indigestion
Wind / Burping
Topical preparations may cause skin irritation, itchiness or a rash.
It is advised that the patient stop using Nifedipine if any of these symptoms become serious or they experience
Fast/Irregular Heart Beat
Sudden Allergic Reaction
1mL of 10% (100mg/mL) is to be applied twice a day to a clean wound, using a finger cot* and massaged into the skin and up towards the ankle, followed by appropriate bandaging. It is recommended but not necessary for the patient to elevate the foot as much as possible and avoid walking barefoot or applying excess pressure to the area.
The Doctor may change the concentration of the preparation if see fit, however this must be noted.
*Avoid contact with non-affected areas*
An assessment sheet will need to be filled in every 4 weeks in between and after treatment as a means to measure healing and effectiveness.
Please let us know if you would like any of your patients to take part in this trail and we will forward all relevant documentation to you and your patients.
If you have any questions pertaining to the trail please do not hesitate to contact any one of our compounding pharmacists on 9272 8726.