Pharmacoepidemiology of Three Commonly Used Cellular/Tissue Derived Products for the Treatment of Venous Leg
Ulcers in Outpatient Care Settings
Adrienne M Gilligan, PhD; Curtis R Waycaster, PhD
Smith & Nephew Biotherapeutics, Fort Worth, TX, USA
INTRODUCTION
RESULTS, continued
 Wounds treated with CTP were, on average, twice as old relative to the overall VLU
 Venous leg ulcers (VLU) are a common and debilitating condition for patients with
population: 12.5, 13.7, and 11.1 months for ECM, HSE, and LSE, respectively [Figure 3].
venous insufficiency. 1-2
 Compression therapy is the standard care for the treatment of VLU; however the
Figure 3: : Average Wound Age (in Months) for CTP versus Non-CTP Patients
success rate is approximately 50% at 6 months.1
 Clinical trials with cellular/tissue derived products (CTP) have shown promising efficacy
for the treatment of VLU.3-6
OBJECTIVES
Identify VLU patient and clinical characteristics and examine patterns of CTP utilization.
METHODS
 Retrospective, de-identified electronic medical records from 2007-2012 were extracted
from the Intellicure Limited Data Set (I-LDS).
 The I-LDS extracts records from 96 hospital-based outpatient wound centers.
 Patient, wound, and encounter level characteristics were examined.
 CTP of interest included extracellular matrix (ECM), human skin equivalent (HSE), and
living skin equivalent (LSE).
 The average number of applications for ECM was 2.7 (SD=2.8), 1.0 (SD=1.3) for HSE, and
3.1 (SD=3.3) for LSE [Figure 4].
RESULTS
Figure 4: Average Number of CTP Applications
 A total of 9,091 patients, 25,734 wounds, and 222,666 visits for VLU were identified
[Figure 1].
 The majority of patients were male (50.5%), Caucasian (74.1%), and reported Medicare
as their primary insurance (53.4%) [Table 1].
Figure 1: Venous Leg Ulcer Population
 Overall average treatment time for the VLU population was 2.9 months (SD=4.8).
 Treatment time was significantly longer with CTP utilization; average time was 9.6, 9.7,
and 7.5 months for ECM, HSE, and LSE, respectively [Figure 5].
Figure 5: Average Treatment Time (in Months) for CTP versus Non-CTP Patients
Table 1: Clinical and Demographic Characteristics for Overall VLU Population
CONCLUSIONS
 Of the 25,734 wounds, approximately 7.1% received commonly used CTP [Figure 2]:
1. ECM (Oasis®) [3.4%]
2. HSE (Apligraf®) [3.5%]
3. LSE (Dermagraft®) [0.2%]
 The overall average wound age was 5.8 months (SD=26.7).
Figure 2: Wounds Treated with CTP
 CTP utilization was relatively low for treatment of VLU within outpatient wound centers.
 Results from this analysis indicate that health care providers are using CTP in older,
more difficult-to-heal VLU.
 Given the absence of head-to-head trials, the use of a large, nationally representative
wound registry can help to establish the clinical and cost efficacy of CTPs for treatment
of VLU to inform clinical practice and healthcare decision makers.
REFERENCES
1. O'Meara S, Cullum N, Nelson EA, Dumville JC: Compression for venous leg ulcers. Cochrane Database Syst Rev
2012;11:CD000265.
2. Edwards H, Courtney M, Finlayson K, Shuter P, Lindsay E: A randomised controlled trial of a community nursing intervention: Improved quality of life and healing for clients with chronic leg ulcers. J Clin Nurs 2009;18:1541-1549.
3. Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D: Effectiveness of an extracellular matrix graft (oasis wound matrix) in the treatment of chronic leg ulcers: A randomized clinical trial. J Vasc Surg 2005;41:837-843.
4. Falanga V, Margolis D, Alvarez O, Auletta M, Maggiacomo F, Altman M, Jensen J, Sabolinski M, Hardin-Young J: Rapid
healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Human skin
equivalent investigators group. Arch Dermatol 1998;134:293-300.
5. Krishnamoorthy L, Harding K, Griffiths D: The clinical and histological effects of dermagraft® in the healing of chronic
venous leg ulcers. Phlebotomy 2003;18:12-22.
6. Omar AA, Mavor AI, Jones AM, Homer-Vanniasinkam S: Treatment of venous leg ulcers with dermagraft. Eur J Vasc
Endovasc Surg 2004;27:666-672.
ACKNOWLEDGEMENTS
TRADEMARKS All trademarks are the property of their respective owners.
The authors are grateful to Ms. Renée Carstens for assistance in design and layout of this poster
This study was supported by Smith & Nephew Biotherapeutics.