Apligraf® in Practice – Dr. Steinberg
Case presented by John S. Steinberg, DPM, Assistant Professor, Department of Orthopaedics/Podiatry Service, The University of Texas Health Science Center at San Antonio, San Antonio, Texas.
Patient: H.A.*
Wound: Diabetic foot ulcer†
Age: 51 years old
Sex: Male
Duration of the condition: 2 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
H.A. is a 51-year-old Caucasian male with hypertension and a 3-year history of type 2 diabetes. H.A. had a partial 1st ray and 2nd toe amputation of the left foot in 1998. Following the amputation, increased pressure to the forefoot led to the development of the diabetic foot ulcer. A split-thickness skin graft in 1998 failed to heal the wound. Over the following 2 years, the ulcer resisted treatment with recombinant platelet-derived growth factor, hyperbaric oxygen, and local wound care including debridement, saline dressings and off-loading.
Evaluation
Figure 2:
Week 0 - Application.
A neurological examination of H.A. revealed a loss of protective sensation to both feet, and a musculoskeletal evaluation indicated a bilateral gastroc-soleal equinus deformity. Posterior tibial/dorsalis pedis pulses were palpable, and a Doppler exam revealed triphasic waveforms to feet and digits bilaterally. The ulcer measured 3.5 cm x 2.5 cm x 0.75 cm prior to Apligraf application. The ulcer was evaluated as grade 1A by the University of Texas grading system1 indicating a clean, nonischemic, full-thickness skin wound. The wound had granulation tissue present and no apparent signs of infection.
Treatment
Figure 3:
Week 1 - Ulcer depth reduced. New epidermal and dermal tissue at the edge of the ulcer.
The ulcer received weekly debridement, saline dressings, and off-loading for 2 months prior to application of Apligraf. A percutaneous Achilles' tendon—lengthening procedure was performed concurrently with Apligraf application in order to address the gastroc-soleal equinus deformity. Apligraf was fenestrated (perforated) to allow for drainage and prevent the buildup of fluid. Apligraf was applied to the wound bed, trimmed to overlap the wound margins by 1.5 cm, and secured in place by suturing with 3-0 Prolene™. Apligraf was covered with Tegapore™, moist gauze, petroleum gauze, dry dressing, and Coban™. The patient was placed in a wheelchair and a posterior splint to ensure total off-loading during the first 4 weeks, and continued with the posterior splint for the remainder of therapy. Dressings were changed at 5 days postapplication and weekly thereafter.
Clinical Observations
Figure 4:
Week 5 - Complete closure (full epithelization and lack of drainage).
- Preapplication (Figure 1): Just prior to application of Apligraf, the ulcer shows a granulating wound bed and no apparent signs of infection. The wound has been surgically debrided to remove necrotic tissue, expose the true size of the wound, and to prepare the wound bed for Apligraf.
- Application (Figure 2): Fenestrated Apligraf has been applied to the ulcer, trimmed to overlap the wound edges by 1.5 cm, and secured in place with 3-0 Prolene sutures.
- Week 1 (Figure 3): After application of Apligraf, the depth of the ulcer was reduced. Note new epidermal and dermal tissue at the edge of the ulcer. H.A. admitted to getting the dressings wet on 2 occasions, which led to the macerated appearance around the periphery of the ulcer.
- Week 5 (Figure 4): Thirty-three days after application of Apligraf, the wound showed complete closure (full epithelization and lack of drainage).
- Week 16 (Figure 5): The wound is completely closed and remodeling has occurred.
Discussion
Figure 5:
Week 16 - Complete closure and remodeling.
H.A.'s diabetic foot ulcer was resistant to previous therapies, including a split-thickness skin graft and recombinant platelet-derived growth factor, attempted over a 2-year span. Utilizing Apligraf, complete epithelization was achieved in 33 days. The patient is now wearing extra-depth shoes with custom-molded Plastozote® insoles.
The patient relates this is the first time in over 2 years he has been without a dressing on his foot and able to wear a shoe.
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. Lavery LA, Armstrong DG, Harkless LB. Classification of diabetic foot wounds. J Foot Ankle Surg. 1996;35:528-531.