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EFFECTS OF OFF-LOADING CHRONIC PLANTAR PEDAL ULCERATIONS USING TOTAL CONTACT CASTING INTRODUCTION Off-loading a pressure ulcer is essential in treating the neuropathic foot. Total contact casting (TCC) is the gold standard for off-loading plantar wounds with proven efficacy. 1 However, TCC is widely underutilized nationwide and removable off-loading devices are more commonly used, though less effective. 2-4 We present a case series of long standing wounds that were unresponsive to other wound care modalities that responded impressively once TCC was initiated. PURPOSE To illustrate how chronic plantar ulcerations that failed treatment with removable off-loading devices progressed to closure after initiation of Total Contact Casting (TCC). OBJECTIVE To obtain healing in chronic plantar ulcerations that persisted for more than one year. RESULTS The below chart shows the progress each patient’s wound made. Michelle L. Oliver, DPM and Emily D. Rose, DPM Mercy Fitzgerald Hospital: Advanced Wound Care Center, Darby, PA CONCLUSIONS The findings of all three patients utilizing the Roll on TCC system were impressive. Two patients’ wounds completely closed after 2 months of Roll on TCC system. One of the patient’s total wound area had decreased below one half of the initial measurements after four months of casting and is near complete closure. No complications were observed with the Roll on TCC system. This case series demonstrates that wounds that did not progress to healing with other methods of off-loading and advanced therapies did progress to closure once the Roll on TCC system was implemented. METHODS Three patients were identified with non-healing ulcerations of greater than one year duration; the longest being six years. Two patients’ co-morbidities are diabetes and hypertension. All patients are morbidly obese and have peripheral neuropathy. All patients attempted and failed a multitude of treatments such as: collagens, silver dressings, foams, and skin substitutes * . Two patients also had biopsies, vacuum assisted closure devices, and aggressive surgical debridements. All had concurrent use of removable off-loading devices. Patients were selected based on the chronicity of their wound and the failure of clinical progress utilizing other off-loading devices. A roll on TCC system ** was applied in all patients and changed weekly with concurrent serial debridements. References: 1. Boulton, A.J.M. Pressure and the diabetic foot: clinical science and offloading techniques. American Journal of Surgery 187 (2004). 2. Fife, C.E., Carter, M.J., Walker, D., Thomson, B. & Eckert, K.A. Diabetic foot ulcer off-loading: the gap between evidence and practice. Data from the US wound registry. Advances in Skin and Wound Care 27;7 (2014). 3. Fife, C.E., Carter, M.J., Walker D. Why is it so hard to do the right thing in wound care?. Wound Repair and Regeneration 18, 154-158, (2010). 4. Lavery, L.A., Higgins, K.R., La Fontaine, J., Zamorano, R.G., Constantinides, G.P. & Kim, P.J. Randomised clinical trial to compare total contact cast, healing sandals and a shear reducing removable boot to heal diabetic foot ulcers. International Wound Journal 2014. CASE 1 46 year old male with PMH of: morbid obesity (BMI 45.1), HTN, HLD, peripheral neuropathy and former tobacco use with a history of multiple chronic foot wounds over the past 3 years. He was followed at our institution for a right submetatarsal head ulcer since 7/2013 that had been present after a callus peeled off to reveal a wound. He underwent multiple treatments including vacuum assisted closure, skin substitutes, multiple debridements and off-loading with a removable device *** without healing. The Roll on TCC system was initiated on 5/19/14, wound measured 1.3 cm x 1.3 cm x 0.3 cm (1.7 cm 2 ), with healing achieved by 7/28/14 (11 weeks). He had a subsequent wound recurrence 8/5/14 secondary to excessive walking without off-loading. This was closed by 8/25/14 (3 weeks) in Roll on TCC system and is closed to date with five months of follow up. CASE 2 43 year old male with PMH of: morbid obesity (BMI 41.7) HTN, HLD, DM II, tobacco use and multiple chronic foot wounds followed for right submetatarsal 1 wound present since 5/2013. Initial wound measurement at presentation was 2.3 cm x 2.9 cm x 0.2 cm (6.7 cm 2 ). This ulcer was treated with collagen, silver dressings, skin substitutes, surgical debridement, tissue biopsy and removable off-loading without significant progression to healing. The Roll on TCC system was initiated for this wound on 7/21/14 measuring 2 cm x 2.5 cm x 0.2 cm (5 cm 2 ) with full healing achieved by 9/26/14, (11 weeks). The wound remains closed to date with five months of follow up. CASE 3 55 year old male PMH of: DM II, morbid obesity (BMI 40.9), HTN, Charcot neuroarthropathy reconstruction with external fixator, active tobacco use and amputations right 4th and 5th toes followed for right plantar 5th metatarsal base ulcer present for 6 years. He had undergone multiple treatments prior to referral. Initial evaluation measurement at our institution was 2.7 cm x 3 cm x 0.3 cm (8.1 cm 2 ). During his treatment course, he underwent removable off-loading, wound biopsy and skin substitutes. The maximum wound measurement during treatment was 9.8 cm 2 . TCC was initiated 7/11/14 at 1.4 cm x 1.2 cm x 0.2 cm (1.7cm 2 ). He remains unhealed, but currently measures 1.2 cm x 0.7 cm x 0.2 cm (0.8 cm 2 ), half of his initial wound size at the beginning of the casting period. 5/9/14 7/21/14 9/26/14 3/11/14 7/11/14 8/25/14 * Oasis, Smith & Nephew, London: and Apligraf/Dermagraf, Organogenesis,Canton,MA ** TCC-EZ ® Total Contact Cast System, Derma Sciences Inc., Princeton, NJ. *** Ortho Wedge, Darco, Huntington, WV; and DH Offloading Walker, Ossur, Orange County, CA Derma Sciences provided an educational grant to support this research. The information may include a use that has not been approved or cleared by the Food and Drug Administration. This information is not being presented on behalf of Derma Sciences. Case Initial wound size (cm 2 ) Initial cast date Closure date Time to closure Case 1 1.7 5/19/14 8/25/14 15 weeks Case 2 5 7/21/14 9/26/14 11 weeks Case 3 1.7 7/11/14 --- --- Presented at SAWC Fall 2015, Las Vegas 0668732-1-EN

Mercy Fitzgerald Hospital: Advanced Wound Care Center ... · Mercy Fitzgerald Hospital: Advanced Wound Care Center, Darby, PA CONCLUSIONS The findings of all three patients utilizing

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EFFECTS OF OFF-LOADING CHRONIC PLANTAR PEDAL ULCERATIONS USING TOTAL CONTACT CASTING

INTRODUCTIONOff-loading a pressure ulcer is essential in treating the neuropathic foot. Total contact casting (TCC) is the gold standard for off-loading plantar wounds with proven efficacy.1 However, TCC is widely underutilized nationwide and removable off-loading devices are more commonly used, though less effective.2-4 We present a case series of long standing wounds that were unresponsive to other wound care modalities that responded impressively once TCC was initiated.

PURPOSETo illustrate how chronic plantar ulcerations that failed treatment with removable off-loading devices progressed to closure after initiation of Total Contact Casting (TCC).

OBJECTIVETo obtain healing in chronic plantar ulcerations that persisted for more than one year.

RESULTSThe below chart shows the progress each patient’s wound made.

Michelle L. Oliver, DPM and Emily D. Rose, DPM Mercy Fitzgerald Hospital: Advanced Wound Care Center, Darby, PA

CONCLUSIONSThe findings of all three patients utilizing the Roll on TCC system were impressive. Two patients’ wounds completely closed after 2 months of Roll on TCC system. One of the patient’s total wound area had decreased below one half of the initial measurements after four months of casting and is near complete closure. No complications were observed with the Roll on TCC system. This case series demonstrates that wounds that did not progress to healing with other methods of off-loading and advanced therapies did progress to closure once the Roll on TCC system was implemented.

METHODSThree patients were identified with non-healing ulcerations of greater than one year duration; the longest being six years. Two patients’ co-morbidities are diabetes and hypertension. All patients are morbidly obese and have peripheral neuropathy. All patients attempted and failed a multitude of treatments such as: collagens, silver dressings, foams, and skin substitutes*. Two patients also had biopsies, vacuum assisted closure devices, and aggressive surgical debridements. All had concurrent use of removable off-loading devices. Patients were selected based on the chronicity of their wound and the failure of clinical progress utilizing other off-loading devices. A roll on TCC system** was applied in all patients and changed weekly with concurrent serial debridements.

References: 1. Boulton, A.J.M. Pressure and the diabetic foot: clinical science and offloading techniques. American Journal of Surgery 187 (2004). 2. Fife, C.E., Carter, M.J., Walker, D., Thomson, B. & Eckert, K.A. Diabetic foot ulcer off-loading: the gap between evidence and practice. Data from the US wound registry. Advances in Skin and Wound Care 27;7 (2014). 3. Fife, C.E., Carter, M.J., Walker D. Why is it so hard to do the right thing in wound care?. Wound Repair and Regeneration 18, 154-158, (2010). 4. Lavery, L.A., Higgins, K.R., La Fontaine, J., Zamorano, R.G., Constantinides, G.P. & Kim, P.J. Randomised clinical trial to compare total contact cast, healing sandals and a shear reducing removable boot to heal diabetic foot ulcers. International Wound Journal 2014.

CASE 146 year old male with PMH of: morbid obesity (BMI 45.1), HTN, HLD, peripheral neuropathy and former tobacco use with a history of multiple chronic foot wounds over the past 3 years. He was followed at our institution for a right submetatarsal head ulcer since 7/2013 that had been present after a callus peeled off to reveal a wound. He underwent multiple treatments including vacuum assisted closure, skin substitutes, multiple debridements and off-loading with a removable device*** without healing. The Roll on TCC system was initiated on 5/19/14, wound measured 1.3 cm x 1.3 cm x 0.3 cm (1.7 cm2), with healing achieved by 7/28/14 (11 weeks). He had a subsequent wound recurrence 8/5/14 secondary to excessive walking without off-loading. This was closed by 8/25/14 (3 weeks) in Roll on TCC system and is closed to date with five months of follow up.

CASE 243 year old male with PMH of: morbid obesity (BMI 41.7) HTN, HLD, DM II, tobacco use and multiple chronic foot wounds followed for right submetatarsal 1 wound present since 5/2013. Initial wound measurement at presentation was 2.3 cm x 2.9 cm x 0.2 cm (6.7 cm2). This ulcer was treated with collagen, silver dressings, skin substitutes, surgical debridement, tissue biopsy and removable off-loading without significant progression to healing. The Roll on TCC system was initiated for this wound on 7/21/14 measuring 2 cm x 2.5 cm x 0.2 cm (5 cm2) with full healing achieved by 9/26/14, (11 weeks). The wound remains closed to date with five months of follow up.

CASE 355 year old male PMH of: DM II, morbid obesity (BMI 40.9), HTN, Charcot neuroarthropathy reconstruction with external fixator, active tobacco use and amputations right 4th and 5th toes followed for right plantar 5th metatarsal base ulcer present for 6 years. He had undergone multiple treatments prior to referral. Initial evaluation measurement at our institution was 2.7 cm x 3 cm x 0.3 cm (8.1 cm2). During his treatment course, he underwent removable off-loading, wound biopsy and skin substitutes. The maximum wound measurement during treatment was 9.8 cm2. TCC was initiated 7/11/14 at 1.4 cm x 1.2 cm x 0.2 cm (1.7cm2). He remains unhealed, but currently measures 1.2 cm x 0.7 cm x 0.2 cm (0.8 cm2), half of his initial wound size at the beginning of the casting period.

5/9/14 7/21/14

9/26/14

3/11/14

7/11/148/25/14

*Oasis, Smith & Nephew, London: and Apligraf/Dermagraf, Organogenesis,Canton,MA**TCC-EZ® Total Contact Cast System, Derma Sciences Inc., Princeton, NJ. ***Ortho Wedge, Darco, Huntington, WV; and DH Offloading Walker, Ossur, Orange County, CA

Derma Sciences provided an educational grant to support this research. The information may include a use that has not been approved or cleared by the Food and Drug Administration. This information is not being presented on behalf of Derma Sciences.

Case Initial wound size (cm2) Initial cast date Closure date Time to closure

Case 1 1.7 5/19/14 8/25/14 15 weeks

Case 2 5 7/21/14 9/26/14 11 weeks

Case 3 1.7 7/11/14 --- ---

Presented at SAWC Fall 2015, Las Vegas 0668732-1-EN