Pressure Offloading Injectable System (POIS): Evaluating the use of an injectable dermal filler for offloading painful pressure points during weight bearing activities

Authors

  • Jodi Schoenhaus, DPM Foot, Ankle & Vein Center, Boca Raton, FL, USA
  • Jason Gold, DPM Foot, Ankle & Vein Center, Boca Raton, FL, USA
  • Aaron McFarlane Research subinvestigator

DOI:

https://doi.org/10.55067/jifaf.v1i10.33

Keywords:

Foot and Ankle Disability Index (FADI) score, dermal filler,, fat pad atrophy, fat pad restoration, foot pad cushioning, heel pain, Juvederm® Voluma XC, TOG GaitScanTM, metatarsalgia, pressure ulceration

Abstract

Fat pad atrophy is a condition characterized by the loss of natural fat on the plantar aspect of the foot. Fat pad restoration techniques directly address fat pad atrophy by increasing the overall thickness of subcutaneous tissue in the foot. Two subtypes of fat pad restoration, surgical dermal allograft and autolipotransplantation, are well-characterized treatment options for offloading high pressure regions of the foot. These methods have previously been shown to result in significant decreases in pain, improvement in the overall quality of life and decreases in the progression of dermal breakdown. However, the efficacy of a novel subtype of fat pad restoration, dermal injectables, is poorly characterized.  This prospective, within-subjects design trial of thirty participants evaluated the safety and efficacy of an injectable hyaluronic acid dermal filler by measuring quality of life scores, ultrasound subcutaneous tissue thickness and gait pressure analysis. Each participant was followed for a one-year period with each study variable analyzed at 2 weeks, 12 weeks, 24 weeks and 54 weeks post-injection.  Our study results revealed that a 1 milliliter injection of Juvederm® Voluma XC into regions of the foot with fat pad atrophy resulted in significantly higher Foot and Ankle Disability Index (FADI) scores over 54 weeks post-injection (p < 0.001, versus baseline), and significantly higher subcutaneous layer thickness over 54 weeks post-injection (p < 0.01, versus baseline), while no significant changes in the impulse gait percentages throughout the course of the study were evident (p >> 0.05, versus baseline). While follow-up studies are necessary, our preliminary study strongly suggests that Juvederm® Voluma XC (and other similar injectable dermal fillers) may present an efficacious, non-invasive, alternative treatment option to address fat pad atrophy.

References

Kao PF, Davis BL, Hardy PA. Characterization of the calcaneal fat pad in diabetic and non-diabetic patients using magnetic resonance imaging. Magn Reson Imaging. 1999 Jul;17(6):851-7. doi: 10.1016/s0730-725x(99)00019-3. PMID: 10402592.

Snow RE, Williams KR, Holmes GB Jr. The effects of wearing high heeled shoes on pedal pressure in women. Foot Ankle. 1992 Feb;13(2):85-92. doi: 10.1177/107110079201300206. PMID: 1572591.

Lopez-Lopez D, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Soriano-Medrano A, Palomo-Lopez P, Morales-Ponce A, Rodriguez-Sanz D, Calvo-Lobo C. Relationship Between Decreased Subcalcaneal Fat Pad Thickness and Plantar Heel Pain. A Case Control Study. Pain Physician. 2019 Jan;22(1):109-116. PMID: 30700074.

Gooding GA, Stress RM, Graf PM, Grunfeld C. Heel pad thickness: determination by high-resolution ultrasonography. J Ultrasound Med. 1985 Apr;4(4):173-4. doi: 10.7863/jum.1985.4.4.173. PMID: 3886923.

Dalal S, Widgerow AD, Evans GR. The plantar fat pad and the diabetic foot--a review. Int Wound J. 2015 Dec;12(6):636-40. doi: 10.1111/iwj.12173. Epub 2013 Oct 17. PMID: 24131727; PMCID: PMC7950511.

Wrobel JS, Najafi B. Diabetic foot biomechanics and gait dysfunction. J Diabetes Sci Technol. 2010 Jul 1;4(4):833-45. doi: 10.1177/193229681000400411. PMID: 20663446; PMCID: PMC2909514.

Oh S, Kim J, Choi J, Jeong W, Chang H, Lee S. Comparison of Pedal Soft Tissue Thickness Between Those With and Without Diabetes. J Foot Ankle Surg. 2018 Sep-Oct;57(5):860-864. doi: 10.1053/j.jfas.2018.02.003. Epub 2018 May 18. PMID: 29784531.

Jahss MH, Kummer F, Michelson JD. Investigations into the fat pads of the sole of the foot: heel pressure studies. Foot Ankle. 1992 Jun;13(5):227-32. doi: 10.1177/107110079201300501. PMID: 1624185.

Buschmann WR, Jahss MH, Kummer F, Desai P, Gee RO, Ricci JL. Histology and histomorphometric analysis of the normal and atrophic heel fat pad. Foot Ankle Int. 1995 May;16(5):254-8. doi: 10.1177/107110079501600502. PMID: 7633580.

Waldecker U. Plantar fat pad atrophy: a cause of metatarsalgia? J Foot Ankle Surg. 2001 Jan-Feb;40(1):21-7. doi: 10.1016/s1067-2516(01)80037-5. PMID: 11202764.

Kordonouri O, Biester T, Schnell K, Hartmann R, Tsioli C, Fath M, Datz N, Danne T. Lipoatrophy in children with type 1 diabetes: an increasing incidence? J Diabetes Sci Technol. 2015 Mar;9(2):206-8. doi: 10.1177/1932296814558348. Epub 2014 Nov 18. PMID: 25411060; PMCID: PMC4604570.

Webster JM, Kempen LJAP, Hardy RS, Langen RCJ. Inflammation and Skeletal Muscle Wasting During Cachexia. Front Physiol. 2020 Nov 19;11:597675. doi: 10.3389/fphys.2020.597675. PMID: 33329046; PMCID: PMC7710765.

Dimonte P, Light H. Pathomechanics, gait deviations, and treatment of the rheumatoid foot: a clinical report. Phys Ther. 1982 Aug;62(8):1148-56. doi: 10.1093/ptj/62.8.1148. PMID: 7100272.

Vanni H, Kazeros A, Wang R, Harvey BG, Ferris B, De BP, Carolan BJ, Hübner RH, O'Connor TP, Crystal RG. Cigarette smoking induces overexpression of a fat-depleting gene AZGP1 in the human. Chest. 2009 May;135(5):1197-1208. doi: 10.1378/chest.08-1024. Epub 2009 Feb 2. PMID: 19188554; PMCID: PMC2679098.

Yıldırım MA, Öneş K, Gökşenoğlu G. Skin depigmentation and subcutaneous fat atrophy after corticosteroid injection for lateral epicondylitis in two elbow. Agri. 2022 Jan;34(1):60-62. English. doi: 10.14744/agri.2019.69320. PMID: 34988965.

Holland C, Jaeger L, Smentkowski U, Weber B, Otto C. Septic and aseptic complications of corticosteroid injections: an assessment of 278 cases reviewed by expert commissions and mediation boards from 2005 to 2009. Dtsch Arztebl Int. 2012 Jun;109(24):425-30. doi: 10.3238/arztebl.2012.0425. Epub 2012 Jun 15. PMID: 22787504; PMCID: PMC3394381.

Mickle KJ, Munro BJ, Lord SR, Menz HB, Steele JR. Soft tissue thickness under the metatarsal heads is reduced in older people with toe deformities. J Orthop Res. 2011 Jul;29(7):1042-6. doi: 10.1002/jor.21328. Epub 2011 Feb 24. PMID: 21567451.

Zirngibl B, Grifka J, Baier C, Götz J. Hallux valgus : Ätiologie, diagnostische und therapeutische Prinzipien [Hallux valgus : Etiology, diagnosis, and therapeutic principles]. Orthopade. 2017 Mar;46(3):283-296. German. doi: 10.1007/s00132-017-3397-3. PMID: 28251259.

Moore ES, Kindig MW, McKearney DA, Telfer S, Sangeorzan BJ, Ledoux WR. Hind- and midfoot bone morphology varies with foot type and sex. J Orthop Res. 2019 Mar;37(3):744-759. doi: 10.1002/jor.24197. Epub 2019 Jan 16. PMID: 30537297.

Golightly YM, Hannan MT, Dufour AB, Renner JB, Jordan JM. Factors associated with hallux valgus in a community-based cross-sectional study of adults with and without osteoarthritis. Arthritis Care Res (Hoboken). 2015 May;67(6):791-8. doi: 10.1002/acr.22517. PMID: 25418024; PMCID: PMC4440851.

Moayedi M, Arshi AR, Salehi M, Akrami M, Naemi R. Associations between changes in loading pattern, deformity, and internal stresses at the foot with hammer toe during walking; a finite element approach. Comput Biol Med. 2021 Aug;135:104598. doi: 10.1016/j.compbiomed.2021.104598. Epub 2021 Jun 22. PMID: 34346320.

Freeman DB. Corns and calluses resulting from mechanical hyperkeratosis. Am Fam Physician. 2002 Jun 1;65(11):2277-80. PMID: 12074526.

Volmer-Thole M, Lobmann R. Neuropathy and Diabetic Foot Syndrome. Int J Mol Sci. 2016 Jun 10;17(6):917. doi: 10.3390/ijms17060917. PMID: 27294922; PMCID: PMC4926450.

Reardon R, Simring D, Kim B, Mortensen J, Williams D, Leslie A. The diabetic foot ulcer. Aust J Gen Pract. 2020 May;49(5):250-255. doi: 10.31128/AJGP-11-19-5161. PMID: 32416652.

Boulton AJ. Clinical presentation and management of diabetic neuropathy and foot ulceration. Diabet Med. 1991;8 Spec No:S52-7. doi: 10.1111/j.1464-5491.1991.tb02157.x. PMID: 1825959.

Gusenoff JA, Mitchell RT, Jeong K, Wukich DK, Gusenoff BR. Autologous Fat Grafting for Pedal Fat Pad Atrophy: A Prospective Randomized Clinical Trial. Plast Reconstr Surg. 2016 Nov;138(5):1099-1108. doi: 10.1097/PRS.0000000000002667. PMID: 27391833.

Crisologo PA, Lavery LA, Fontaine J. Conservative Offloading. Clin Podiatr Med Surg. 2019 Jul;36(3):371-379. doi: 10.1016/j.cpm.2019.02.003. Epub 2019 Apr 6. PMID: 31079604.

Mazur F, Swoboda B, Carl HD, Lutter C, Engelhardt M, Hoppe MW, Hotfiel T, Grim C. Plantar pressure changes in hindfoot relief devices of different designs. J Exp Orthop. 2019 Feb 7;6(1):7. doi: 10.1186/s40634-019-0173-9. PMID: 30729337; PMCID: PMC6367492.

Park CH, Chang MC. Forefoot disorders and conservative treatment. Yeungnam Univ J Med. 2019 May;36(2):92-98. doi: 10.12701/yujm.2019.00185. Epub 2019 May 14. PMID: 31620619; PMCID: PMC6784640.

Ali NS, Hoss E, Kollipara R, Goldman MP. Hyaluronic Acid Filler for Treatment of Metatarsal Fat Pad Atrophy. Dermatol Surg. 2021 Jul 1;47(7):1034-1035. doi: 10.1097/DSS.0000000000002999. PMID: 33731566.

Foumenteze JP, Simpson H, Kerrouche N. Hyaluronic Acid Filler Injections Under the Metatarsal Heads Provide a Significant and Long-Lasting Improvement in Metatarsalgia From Wearing High-Heeled Shoes. Dermatol Surg. 2018 Jul;44(7):994-1001. doi: 10.1097/DSS.0000000000001470. PMID: 29360658; PMCID: PMC6039379.

Chairman EL. Restoration of the plantar fat pad with autolipotransplantation. J Foot Ankle Surg. 1994 Jul-Aug;33(4):373-9. PMID: 7951190.

Rocchio TM. Augmentation of atrophic plantar soft tissue with an acellular dermal allograft: a series review. Clin Podiatr Med Surg. 2009 Oct;26(4):545-57. doi: 10.1016/j.cpm.2009.07.001. PMID: 19778688.

Hale SA, Hertel J. Reliability and Sensitivity of the Foot and Ankle Disability Index in Subjects With Chronic Ankle Instability. J Athl Train. 2005 Mar;40(1):35-40. PMID: 15902322; PMCID: PMC1088343.

Balkin SW. Plantar keratoses: treatment by injectable liquid silicone. Report of an eight-year experience. Clin Orthop Relat Res. 1972 Sep;87:235-47. PMID: 5078036.

Balkin SW. Silicone injection for plantar keratoses. Preliminary report. J Am Podiatry Assoc. 1966 Jan;56(1):1-11. doi: 10.7547/87507315-56-1-1. PMID: 5903257.

Balkin SW. Treatment of painful scars on soles and digits with injections of fluid silicone. J Dermatol Surg Oncol. 1977 Nov-Dec;3(6):612-4. doi: 10.1111/j.1524-4725.1977.tb00367.x. PMID: 145448.

Balkin SW. The fluid silicone prosthesis. Clin Podiatry. 1984 Apr;1(1):145-64. PMID: 6242141.

Balkin SW. Silicone augmentation for plantar calluses. J Am Podiatry Assoc. 1976 Mar;66(3):148-54. doi: 10.7547/87507315-66-3-148. PMID: 1254893.

Balkin SW. Treatment of corns by injectable silicone. Arch Dermatol. 1975 Sep;111(9):1143-5. PMID: 126666.

Balkin SW. Injectable silicone and the foot: a 41-year clinical and histologic history. Dermatol Surg. 2005 Nov;31(11 Pt 2):1555-9; discussion 1560. doi: 10.2310/6350.2005.31241. PMID: 16416638.

Balkin SW, Kaplan L. Silicone injection management of diabetic foot ulcers: a possible model for prevention of pressure ulcers. Decubitus. 1991 Nov;4(4):38-40. PMID: 1760123.

Balkin SW, Rea TH, Kaplan L. Silicone oil prevention of insensitive pressure ulcers. Int J Lepr Other Mycobact Dis. 1997 Sep;65(3):372-4. Erratum in: Int J Lepr Other Mycobact Dis 1998 Dec;66(4):following 609. PMID: 9401491.

van Schie CH, Whalley A, Armstrong DG, Vileikyte L, Boulton AJ. The effect of silicone injections in the diabetic foot on peak plantar pressure and plantar tissue thickness: a 2-year follow-up. Arch Phys Med Rehabil. 2002 Jul;83(7):919-23. doi: 10.1053/apmr.2002.33058. PMID: 12098150.

Maĭborodin IV, Shevela AI, Kuznetsova IV, Barannik MI, Maĭborodina VI. [Tissue responses to silicone materials in the body]. Arkh Patol. 2013 Jul-Aug;75(4):28-33. Russian. PMID: 24313189.

Busch H. Silicone toxicology. Semin Arthritis Rheum. 1994 Aug;24(1 Suppl 1):11-7. doi: 10.1016/0049-0172(94)90104-x. PMID: 7801134.

Morrison T, Jones S, Causby RS, Thoirs K. Reliability of ultrasound in evaluating the plantar skin and fat pad of the foot in the setting of diabetes. PLoS One. 2021 Sep 23;16(9):e0257790. doi: 10.1371/journal.pone.0257790. PMID: 34555088; PMCID: PMC8459958.

Downloads

Published

2022-10-01

How to Cite

1.
Schoenhaus J, Gold J, McFarlane A. Pressure Offloading Injectable System (POIS): Evaluating the use of an injectable dermal filler for offloading painful pressure points during weight bearing activities. J Int Foot Ankle [Internet]. 2022 Oct. 1 [cited 2022 Nov. 29];1(10). Available from: https://internationalfootankle.org/journal/index.php/JIFAF/article/view/33