Cost-effective Design Development of Medicated Footwear for Diabetic Patients

Cost-effective Design Development of Medicated Footwear for Diabetic Patients

Adhir Chandra Paul, Lecturer,

Md. Abdulla-Al-Mamun, Assistant Professor,

Department of Leather Engineering, Khulna University of Engineering &Technology,

Khulna-9203, Bangladesh

Sujit Kumar Ray, & Md. Ashraful Islam, Student (BE),

Department of Leather Engineering, Khulna University of Engineering & Technology,

Khulna-9203, Bangladesh

AbstractDiabetes is one of most common metabolic disease in world-wide. This common metabolic diseases has the risk of amputations including complexity of human body. The medicated footwear provides some attributes such as to reduce the foot ulceration and amputation risk and improves the blood circulation to the legs and feet. This paper is about the development of quality and cost effectiveness of medicated footwear for diabetic patients, which is dramatically decreasing the risk of foot troubles. It also covers the future work that can be done regarding the medicated-footwear development technique for another amputation patient.

Keywords Diabetes, ulcerations, consciousness, medicated footwear, quality enhancement, cost effectiveness.

1. INTRODUCTION

   Diabetes is growing rapidly world-wide. The World Health Organization (WHO) estimates that in 2030 more than 334 millions of persons will suffer from diabetes [1]. Many complications is occurred due to the diabetic. Among one of the most relevant complication called diabetic foot. It often leads to amputation. Peripheral neuropathy, a loss of feeling in the extremities, renders these individuals unaware of sores that develop on their feet until the wound becomes infected. Then, because of other diabetes-related complications, the infection often defies healing and eventually leads to amputation. The main cause of foot ulceration in the adult neuropathy diabetic is thought to be the presence of abnormally high plantar pressures secondary to neuropathy. It is evident that reduction of amputations can be achieved if it is possible to effectively prevent the foot ulceration. Early diagnosis through a continuous foot monitoring can be applied.

   As a person suffering from diabetes definitely need to consider using diabetic footwear, instead of conventional footwear. These types of footwear offer good feet support and they are more comfortable to wear than conventional footwear. These footwear are good to keep our foot healthy and maintain a good lifestyle. It is reported to studied of 60 patients, 30 were male, 30 female. Mean age was 62 years; mean duration of the disease was 17 years. Patients' performance was: 77% adequate moisturizing, 88% proper washing and drying, 83% proper toe-nail cutting, 83% no cuticle trimming, 77% routine shoe inspection, 70% no use of pumice stones or similar abrasive objects, 95% no barefoot walking, but only 5 patients (8.7%) regularly wore the provided footwear. Providing all diabetic patient at risk or

   high risk for foot ulcer and amputations with adequate prevention would be a cost effective or even cost saving strategy [2].

   Furthermore, A better understanding of the link between innovation and cost-effectiveness analysis is particularly important given the large role of technological change in the growth of health care spending. The cost effectiveness was analyzed in the standard export oriented footwear industry context [3]. For this reason, all concerned bodies and industrialists should come forward and take essential steps to set up the diabetic shoe manufacturing plant separately with reasonable cost for diabetic patients so that these shoes can play a vital role to reduce foot ulceration and other risks of diabetic patients. Moreover, diabetic patients also concerned about the difference between medicated and conventional footwear. By using the medicated footwear, it is enabled to high compliance of ulcer prevention and reduces the amputation risk.

   But the best approach is to wear suitable personalized shoes that avoid the causes of ulceration. Despite needs, there is not a full user-centered footwear development due to the difficulty to simultaneously take into consideration multiple design aspects such as foot shape and biomechanics, materials performance for upper, insole and outsole, manufacturing methods. Diabetic shoe is specially designed shoes that feature extra and double depth, come equipped with a removable footbed and removable insole spacers and are finished with a smooth interior lining to reduce the risk of skin abrasions or blister. Moreover, market competition and fast technology change made performance a prerequisite for survival any organization. To cope with this, organizations look for maximising gains [4]. For this fact, cost of a product is most important to both manufacture & buyer. It is needed to keep a level of standard.

   This paper is to bring the object into the adopted footwear design approach and development and for consciousness about diabetic foot troubles. Also it can enhance the quality & effectiveness of cost of footwear that can be mostly demanded for the diabetic holder.

2. METHODOLOGY

   1. Material requirement

      The materials that is required for the development of Medicated footwear:

      Article Title: Medicated footwear. Style: Slip on.

      Last: Wooden. Size: 41.

      Upper Leather: Lamy black, Milled Softy type (thickness: 1.5mm).

      Lining Leather: Goat leather (Brown), thickness: 1.0 mm. Padding: Nylon Mesh Foam, thickness: 5mm.

      Inter Lining: Knitted Fabrics. Sole: Expanded EVA. Insole: Cellulose Board.

      In sock: Multi- Layer, EVA, Foam, Moulded EVA, Leather. Toe Puff: TPR

      Stiffener: TPR.

      Adhesive: Latex, Water based PU/ Rubber solution.

      Sole attaching

      Drying & Heat Reactivation

   2. Working flow diagram

   Think Tank

   Sample Sketch

   Last Selection

   Cutting

   Pattern Development

   Designing

   Marking

   Skiving

   Thread selection

   Stitching

   Back part molding

   Padding

   Closing

   Toe puff attaching

   Mulling & conditioning

   Sole preparation

   Toe, Seat and Side lasting

   Heat setting

   Hard and soft Brushing & Trimming

   Repairing

   Finishing

   Delasting

   Insock & Tack inserting

   Complete Shoe

   Inspection

   Fig.1. Flow Diagram of Developed Medicated Footwear.

3. DESIGN INNOVATION OF MEDICATED FOOTWEAR

   The proposed design approach is based on an integrated product design framework for enabling the management of the whole life cycle of shoes for diabetic people. The approach is based on a set of integrated solidworks software systems. A diabetic patient needs at first specific analysis, in order to evaluate important bio-mechanical parameters (first MPJ motion & torque, plantar pressure, ankle Dorsiflexion, dorsal geometry, foot pronation,etc).This software is used to design the best shoe required to fit the specific needs. In order to measure above parameters, commercial solutions could be sufficiently integrated. Therefore, new measurements devices and the integration of already existing ones in portable systems are going to be investigated. These integrated systems mainly concern foot geometry and pressure acquisition during a complete gait cycle. In the case of insole design of medicated & conventional footwear, pressure & load distribution must be maintained. For this reason the following insole design geometry are shown below.

   Fig.2. Pressure Load distribution on insole into the same plan (In the case of conventional Footwear).

   Fig.3. Pressure Load distribution on insole into the different regions. (In the case of medicated Footwear)

   In standing, the foot acts as a base for the body. Therefore, the larger the area in ground contact the more stable the person.

   From the above Fig.2 illustrates narrow width of shoe and heel being worn, increased pressure on medial border of sole of foot, and instability as weight is unevenly spread.

   Fig.3 Medicated footwear insole increases the contact area which stimulates the total load divided around the forepart of

   the shoe [5]. The geometric views of diabetic shoes are shown below:

   Fig.4. Sketch view of diabetic shoe by solidworks.

   The three most important biomechanical mechanisms by which medicated footwear act can be summarized as follows:

   (i) uppers that protect and relieve stress on the dorsum, yet limit shear motion, (ii) a footed that distributes load and relieves load on high-risk areas, and (iii) outsoles that restrict joint motion and alter load distribution [6]. The single most successful footwear modification yet identified is the rigid rockered or rollered outsole. A number of studies [7-8] have shown that reductions in plantar pressure of up to 50% are possible compared to similar shoes with non rigid soles. Surprisingly, clinical trials to confirm that this efficacy in plantar pressure reduction is reflected in ulcer prevention have not been attempted. Although the placement and design of the rocker certainly influence the amount of relief [9], almost any placement seems to provide some reduction in plantar pressure. Very little patient education is typically given, but wearers of rocker shoes should be encouraged to take short steps to ensure that they are in the toe-off phase of gait before the forward rocker surface contacts the ground and helps to prevent the foot ulceration. By using the medicated footwear, it is enabled to high compliance of ulcer prevention and reduces the amputation risk.

4. COST EFFECTIVENESS ANALYSIS

   When any new technologies are brought to life from costly R&D, consumer surplus may be a poor guide to inducing optimal R&D investments. Currently, CE analysis plays a vital role to satisfy the consumer demand with required attributes paying reasonable price. CE analysis also imply what sorts of accessories would be adopted for gaining feature. In this paper, CE analysis is interpreted based on material which were used in this article and also try to control pricing. Here, the cost was calculated for one pair of medicated footwear in respect of export oriented industry context. Such as:

   Table 1: Cost analysis of medicated footwear

   					I
   ARTICLE	Diabetic Shoe		YEAR/QUARTER				MRP	1500	100.0%
   COLOUR	Black		SIZE RANGE				C O ST	1683.34	112.2%
   SIZE TYPE	French		COST SIZE				Margin	-183.34	-12.2%
   PO NO.	109038		Order. Quant.
   PACK SIZE	41		DATE
   PART NAME	PART NAME	MATERIALS SPECIFICATION	SOURCE	CON. /PAIR		UNIT	PRICE /UNIT	SUB. TOTAL	TOTAL in BDT
   UPPER	UPPER LINING INT. LIN. COMP. OTHERS ADHESIVE THREAD	Leather( upper Lining Leather T/C Back Stiffener Toe Puff Lace Eyelet Glass Wool Neoprene Latex 40/3 60/3	Own Own Own Own Own Own Own Own Own Own Own	3.21 2.4 2.2 1 1 1 0.12 0.045 0.01 30 25		sft sft sft prs prs prs sft kg kg mtr mtr	220.00 170.00 22.00 15.00 10.00 10.00 30.00 245.00 240.00 0.10 0.09	706.20 408 48.4 15 10 10 3.6 11.025 2.4 3 2.25 0	1219.88
   BOTTOM	SOCKS INSOLE SOLE ADHESIVE THREAD	Lining Leather 5 mm Foam Ready Insole per Pair Expanded EVA. PU Adhesive Neopren Adhesive Latex 40/3 60/3	Own Own Own Own Own Own Own Own Own	0.65 0.65 1 1 0.035 0.025 0.01 4 3.5		sft sft prs prs kg kg kg mtr mtr	115.00 15.00 25.00 100.00 250.00 245.00 240.00 0.10 0.09	74.75 9.75 25 100 8.75 6.125 2.4 0.4 0.315	227.49
   CONSU -MABLES		STAMPING FOIL, 20mm EDGE COLOUR, EMERY PAPER NOVA CREAM NEEDLE 110 SILVER PEN RUBBER BAND SOLE & UPPER ATTTACHING P	Own Own Own Own Own Own Own Own	0.02 0.05 0.002 0.002 0.04 0.003 0.0007		roll kg pcs kg pcs pcs kg kg	300.00 60.00 250.00 45.00 25.00 75.00 180.00	0 6 3 0.5 0.09 1 0.225 0.126	10.94
   PACKING		BOX TISSUE PAPER EATURE TAGWITH PLASTIC PI GUM TAPE C. B. CASE	Own Own Own Own Own	1 5 1 0.005 0.05		pcs pcs pcs roll PCS	25.00 0.86 0.03 31.48 111.00	25 4.3 0.0315 0.1574 5.55 0	35.04
   DEVELOPMENT COST								10
   OVERHEAD COST								180.00
   			FACTORY COST =					1683.34
   Value Aided Tax						15% of 1374.79		206.22
   Administrative Cost						7% of 1374.79		96.24
   Operating Cost						3% of 1374.79		41.24
   Total Cost								2027.04
   Profit						50% of 1718.49		859.25
   Grand Total Cost (per pair)								2886.29

   From the above table, the final cost of medicated footwear was reasonable which satisfy the target group and also attainable purchasing capability. Accessories and other materials were collected from our local suppliers. Design technique and fabrication procedure followed from export oriented industry. For that reason, the prime cost of product development was not so high. Most of the factory of medicated footwear producer of our country was not adopt appropriate technique and fabrication process which are helpful for gaining medicated attributes. In practice, the supplied raw materials were available in our country in respect of geographic and religious perspective. In addition, labor cost is the major distinguishable matter in respect of other country. The current product seems appropriate for stimulating the effects of prevention on long term cost associated with foot ulcer and amputation. This study approach can be used for future cost-effectiveness or cost utility analysis of diabetic

   foot ulcer prevention when new technology will be available. Under the study, these design development would be cost- effective or cost-saving in all other patient with diabetes. All diabetic patients at risk or high risk for foot ulcer and amputations with the recommended approach would be cost effective. The recommended designed to promote greater usefulness in case of cost and achieving attributes.

5. RESULTS AND DISCUSSION

   Now-a-days Diabetic patients are increasing day by day. It is not possible to cure diabetic completely with Medicare. But, from the research of Medical science & scientific aspect of footwear manufacturing, it is seen that the medicated footwear

   holding some features which strongly reduces to some extent of diabetes and also control foot ulceration and amputation risks and other disorder. For this reason, it is needed to develop the medicated footwear. In previous studies, it is seen that developed medicated footwear are most costly. As a result,a range of diabetic people are far away from the existing services. According to this consideration, the cost of footwear is the significant factor to obtain services. So, the price of medicated footwear to keep at a standard level of purchase. In these studies, it is tried to accumulate the treatment of diabetic patients by using medicated footwear with the proper cost effectiveness. From the above view of diabetic shoe design by solidworks, new medicated footwear development concept is achieved. The fabrication of different components & material selection process help to develop the modified medicated footwear that is beneficial to diabetic patients.

   A pretty good advantage is obtained from medicated footwear rather than the normal footwear for the diabetic patients.The following features added to the medicated that will differ from normal footwear and it is much more beneficial for diabetic Patients more than normal Footwear.

   Extra deep toe

   Expanded EVA

   Wide opening

   Fig.5. Design construction for medicated footwear.

   The medicated footwear conforms to the contours of the foot, enhancing comfort of the diabetic patients. There are also seamless lining, made of soft fabric, and padded with foam, provide excellent protection of the foot. The only diabetic prefab orthotic with rear foot support that offers an arch filler and long lasting support of the diabetic patients. The

   cushioning sole, with a true toe Spring design, softens the step, and helps propel foot forward and extra-depth design offers a loose fit and freedom for toe movement & hidden depth design offers the appearance of regular depth shoes.

6. CONCLUSIONS

Medicated footwear has been used for decades as one of many strategies to prevent reulceration in patients with diabetes and foot risk factors. The findings of several studies reporting statistically significant protective effects from medicated footwear may have been influenced by several design issues.

Literature overview shows that there is a need of dedicated systems to support the development of shoes for people with diabetes and on the contrary, there are not available technologies to effectively overcome all problems implied in footwear customization, flexibility

,rapidly and quality. So all industrialists and entrepreneur should come forward and take essential steps to develop the definite technology that will be accelerated the much production of medicated footwear. Also this definite technology will help the diabetic patients to reduce the different foot troubles such as ulceration, amputation risk etc

.A general framework based on a KB system for managing the whole shoes development cycle is defined. It sets the basis for innovating the whole process from design to manufacturing and retailing. The paper is focused on the description of the adopted approach to define the design framework and on the preliminary results about the implementation of the solidworks based platform for customized shoes design.

A medicated footwear service can produce significant improvements in mobility and is a valuable adjuvant to be helpful of a programme of care for diabetic people. For the consciousness of the reduction of diabetes, it is needed to develop a innovative medicated footwear & the cost of footwear should be kept with a standard level for customizations.

VII FUTURE DEVELOPMENT OF MEDICATED FOOTWEAR

The development of Medicated footwear is very important for the diabetic patients. In summary, the process of design innovation and development of medicated footwear for people with diabetes is still in a preliminary stage. There is a widespread clinical opinion that footwear can provide primary and secondary prevention of ulceration, but the scientific literature is difficult to interpret because the appropriateness and effectiveness of most footwear used in such studies was not established fully. More research are required for enhancing the development & cost effectiveness of medicated footwear for diabetic patients.

It is hope that the near future will be seen the more widespread use of medicated footwear that has some intelligence in that on-board systems will be available to monitor certain features of the foot-ground interface and

either adapt the properties of the shoe to mitigate undesirable conditions [10-12].The extra quality and more design innovation can be improved in the medicated footwear by using the basement of this work.

ACKNOWLEDGMENT

This research was supported by the Leather Engineering Dept. of Khulna University of Engineering and Technology. The authors would also like to thank Dr. Md. Abul Hashem and Prof. Dr. Mohamed Alamgir for providing insight and expertise that greatly assisted the research.

REFERENCES

1. M. Germani, M. Mandolini, M. Mengoni, R. Raffaeli, E. Montiel, M. Davia,Methods and tools dedicated to shoes customization for people with diabetes,in Proceedings of the IMProVe 2011 International Conference on Innovative Methods in Product Design, June 15th 17th, 2011, Venice, Italy, pp: 698-706, 2011

2. G.Ragnarson TennvaII, J. ApeIqvist, Prevention of diabetes- related foot ulcers and amputations: a cost-utility analysis based onMarkov model simulations, Diabetologia,Springer-Verlag(2001) 44: 20772087,2001.

3. Anupam B. Jena, Tomas J. Philipson, Cost-effectiveness analysis and innovation, Journal of Health Economics 27 (2008),pp. 12241236, 2008.

4. L.B.de M. Guimarães, J.L.D. Ribeiro, J.S. Renner, Cost benefit analysis of a socio-technical intervention in a Brazilian footwear company, Applied Ergonomics 43 (2012),pp. 948-957, 2012.

5. Olwen Finlay Deborah C van de Meer T R O Beringer , Use of Gait Analysis to Demonstrate Benefits of Footwear Assessment in Elderly People, Physiotherapy August 1999/vol 85/no 8, pp.451-456, 1999.

6. Peter R. Cavanagh* , Therapeutic footwear for people with diabetes,DIABETES/METABOLISM RESEARCH AND REVIEWS Diabetes Metab Res Rev 2004; 20(Suppl 1): S51S55. Published online in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/dmrr.435.

7. Coleman WC, Patil KM, Srinivasa H (eds). The Relief of Forefoot Pressures Using Outer Shoe Sole Modifications. Indian Institute of Technology: Madras, India, 1985.

8. Praet SF, Louwerens JW. The influence of shoe design on plantar pressures in neuropathic feet. Diabetes Care 2003; 26: 441445.

9. Van Schie C, Ulbrecht JS, Becker MB, Cavanagh PR. Design criteria for rigid rocker shoes. Foot Ankle Int 2000; 21: 833844.

10. Sabolich JA, OrtegaGM, Schwabe GBIV. System and Method for Providing a Sense of Feel in a Prosthetic or Sensory Impaired Limb.U.S. Patent No. 6,500,210, December 31, 2002.

11. Brantingham CR. Shoe Sole with Randomly Varying Support Pattern.

    U.S. Patent No. 5,179,792, January 19, 1993.

12. Thomas BR, Steinman H, Alley SD. Orthopedic Weight Monitor.U.S. Patent No. 5,253,654, October 19, 1993.