Apligraf® in Practice – Dr. Hanft
Case presented by Jason R. Hanft, DPM, FACFAS, Director of SMH/Baptist Health Systems Diabetes Foot Care Center, Member of MCVI Wound Center, Director of Podiatric Medical Education SMH/Baptist Health Systems, South Miami, Florida.
Patient: E.T.*
Wound: Diabetic foot ulcer†
Age: 69 years old
Sex: Male
Duration of the condition: 3 years
*Not the patient’s real initials.
†The case presented here represents the experience of a single patient and may not be typical of all patients.
History
Figure 1:
Preapplication
E.T. is a 69-year-old male with hypertension, coronary artery disease, and non-insulin-dependent diabetes mellitus (type 2). E.T.'s past surgical history included a quadruple coronary artery bypass, amputation of the 1st metatarsal and hallux, and resection of the 2nd metatarsal head of the right foot. Over a span of more than 2 years, E.T.'s ulcer has shown remarkable resistance to multiple treatments including sharp surgical debridements, moist saline dressings, hydrocolloid dressings, 6 months of recombinant platelet-derived growth factor therapy, and total contact casts. Additionally, the ulcer failed to heal during treatment with an investigational human dermal replacement.
Evaluation
Figure 2:
Day 21 - Complete epithelization and lack of drainage.
The deep diabetic foot ulcer was evaluated as grade 2 on the Wagner scale1 and measured 2.1 cm long x 1.4 cm wide. The ulcer was located on the plantar aspect of the right foot under the 3rd metatarsal head and showed a hyperkeratotic margin with fibrotic borders. A neurological examination of E.T. revealed sensory, motor, and autonomic neuropathy. Musculoskeletal evaluation indicated rigid dislocation of digits 2, 3, 4 and 5 along with anterior advancement of the fat pad, fat pad atrophy and scarring of the plantar skin. Dorsalis pedis and posterior tibial pulses were palpable.
Treatment
Figure 3:
Day 28 - Remodeling of the healed ulcer.
Prior to Apligraf application, the ulcer received sharp surgical debridement to viable tissue and bleeding margins. Fenestrated Apligraf was applied to the wound bed, trimmed to overlap the wound margins by 1 cm and secured in place with 4 surgical staples. Apligraf was covered with Mepitel® (a nonadherent primary dressing) moist saline gauze, Allevyn® (an absorptive secondary dressing), and Dynaflex™ (a multilayered compression system). The patient was prescribed a wheelchair and crutches for the first week following Apligraf application and a Three-D® short leg walker for limited ambulation during the remainder of therapy.
Clinical Observations
- Preapplication (Figure 1): Sharp surgical debridement revealed a deep diabetic foot ulcer with an initial area of 108 mm2.
- Apligraf was fenestrated to allow drainage of wound fluid and promote adherence of Apligraf to the wound bed (not shown). At the first dressing change, the ulcer size was decreased and appeared clean and dry with 100% Apligraf adherence.
- Day 21 (Figure 2): The ulcer has achieved complete closure 3 weeks after application of Apligraf. Complete epithelization occurred.
- Day 28 (Figure 3): Remodeling and maturation of the healed ulcer produced a favorable outcome. The wound has remained closed for at least 5 months.
Discussion
E.T.'s diabetic foot ulcer persisted for over 2 years despite multiple modes of therapy including local wound care, 6 months of topical growth factor therapy and human dermal replacement.
Using Apligraf, the ulcer completely healed in 21 days, allowing E.T. to resume an ambulatory lifestyle and take his first vacation in over 3 years.
Apligraf is indicated for use with standard therapeutic compression for the treatment of noninfected partial-and full-thickness skin ulcers due to venous insufficiency of duration greater than 1 month that have not adequately responded to conventional ulcer therapy.
Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic foot ulcers of greater than 3 weeks duration that have not adequately responded to conventional ulcer therapy and that extend through the dermis but without tendon, muscle, capsule or bone exposure. Apligraf should not be used on infected wounds or on patients with known hypersensitivities to any components of Apligraf or the shipping medium.
Please consult the complete prescribing information for a description of epidermal and dermal elements contained in Apligraf.
*Unless there are clinical signs of infection (pain, swelling, heat, redness, purulent discharge), the wound should be left alone, rebandaged, and reassessed at the next follow-up visit.
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References:
1. Wagner FW. The dysvascular foot: a system for diagnosis and treatment. Foot Ankle. 1981;2:64-122.