European Journal of Cardiovascular Medicine

An understanding of the contributory factors that ultimately result in foot ulceration is likely to help in the planning of effective preventative strategies. There is no doubt that foot ulcers rarely result from a single pathology. The neuropathic foot, for 174 Boulton and Armstrong example, does not spontaneously ulcerate. It is a combination of insensitivity with some other factors that results in ulceration. Such factors may be extrinsic (e.g. Walking barefoot and treading on a sharp object, or simply wearing ill-fitting shoes) or intrinsic (such as the patient with insensitivity and high foot pressures who develops callus that results in ulceration)¹. The breakdown of the diabetic foot has traditionally been considered to result from a combination of neuropathy, vascular disease, and infection. There is, however, no compelling evidence to implicate infection. Infection is normally a consequence rather than a cause of skin breakdown. As noted above, neuropathy is the most important contributory cause in the pathway to ulceration⁵.

Diabetes cases up to 422 million worldwide; India is the top 3^rd country in the world in the prevalence of diabetics’ mellitus. According to the Lancet study, China, India and USA are among the top three countries with a high number of diabetic populations. While the numbers climbed from 20.4 million in China in 1980 to 102.9 million in 2014, the rise has been equally dramatic in India from11.9 million in 1980 to 64.5 million in India. Prevalence of diabetes has more than doubled for men in India and China (3.7 per cent to 9.1 percent in India and 3.5 per cent to 9.9 per cent in China). It has also increased by 50per cent among women in China (5.0 per cent to 7.6 per cent) and 80 per cent among women in India (4.6 per cent to 8.3 per cent). The life time risk of an adult to develop leg ulcer is 2.6% but may be as high as 20% with significant economic consequences for individual and society. Chronic ulcers have a low frequency of spontaneous healing with long duration of healing².

Foot ulcer is a major problem as the complication leading to the high morbidity and mortality to the patients. Most common causes of the foot ulcer are diabetic mellitus, traumatic, and peripheral neuropathy. A diabetic foot ulcer (DFU) can be defined as a full-thickness wound (i.e., involving the subcutaneous tissue) below the ankle, or as a lesion of the foot penetrating through the dermis, in people with type 1 or type 2 diabetes. DFU is the leading cause of lower-extremity amputation and hospitalization. Once lower extremity amputation due to diabetes has occurred, access to care and treatment seem ineffective in preventing death³. Mortality rate (5 years, unadjusted) post diabetes-related amputation is 39%, comparable to that of colorectal cancer. Peripheral artery disease (PAD) and consequent ischemia are increasingly common in the pathogenesis of DFU, often in combination with neuropathy.

Chronic ulcer means the ulcer shows no tendency towards healing. The floor is covered with pale granulation tissue. Sometimes it shows typical wash- leather slough in gummatous ulcer which is an example of this type. Discharge is scanty or absent. The base is considerably in durated and so is the edge and surrounding skin.

Negative pressure wound therapy as first described by Fleischman et al⁴ in 1993 done in 15 patients with open fractures and reported efficient cleaning and conditioning of the wound with marked increased proliferation of granulation tissue with no bone infection or soft tissue inf

This Hospital based prospective clinical study was conducted in Department of General Surgery, Vinayaka Mission’s Medical College and Hospital, Karaikal. Duration of study was 2YEARS (SEP 2018- SEP 2020). After getting approval from the Ethical committee of the Vinayaka mission’s medical college and hospital, Karaikal, study was conducted. Informed and written consent taken from all the participants. Sample size were 50.

INCLUSION CRITERIA:

• Age between 18 to 65
• Both
• Non healing ulcer both diabetic and non-
• Non infected
• Healthy

EXCLUSION CRITERIA:

• Age<18and>65yrs
• Active
• Any bleeding
• Patients on

      NPWT Therapy setting (usually 125 mm Hg              continuously                   or intermittently 30 min on/15 min off)

      Frequency of dressing changes– usually every 3 days.

      SOURCE OF DATA:

All the patients admitted in the ward with foot ulcer were selected. Patient is examined and allotted for both group.

Directions: Observe and measure the pressure ulcer. Categorize the ulcer with respect to surface area, exudate, and type of wound tissue. Record sub-score for each of these ulcer characteristics. Add the sub-scores to obtain the total score. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing

Length x Width: Measure the greatest length (head to toe) and the greatest width (side to side) using a centimetre ruler. Multiply these two measurements (length x width) to obtain an estimate of surface area in square centimeters (cm2).

Exudate Amount: Estimate the amount of exudate (drainage) present after removal of the dressing and before applying any topical agent to the ulcer. Estimate the exudate (drainage) as none, light, moderate, or heavy.

Tissue Type: This refers to the types of tissue that are present in the wound (ulcer) bed.

Scoreasa“4” if there is any necrotic tissue present.

Score as a“3” if there is any amount of slough present and necrotic tissue is absent.

Score as a“2” if the wound is clean and contains granulation tissue.

Score as 0–Closed/Resurfaced: the wound is completely covered with epithelium (new skin)

Table1 Sex Distribution

In the total study population of 50 patients 52% are male population and 48% are female population. Highestnumberofpopulationbelongstomalesexof52%.

Table2 Distribution of Age

In total of 50 study population mean age distribution of the population was 53.3.

Table 3 Distribution of Comorbid Conditions

In the total study population of 50 patients 52 % of the study population have diabetic mellitus as comorbidity and 14% has hypertension as comorbidity and 14% have both hypertension and diabetic mellitus as co morbidity. 20% of the total study population don’t have any of the comorbidity.

Mean hospital stay is 29.3 with standard error of 1.405.

Table4 Distribution of PUSH Scores

In study population of 50 patients mean deviation of change in the PUSH score is 9.38 with a standard error of 0.391.

Table5 Descriptive Analysis of Wound Size and Hospital Stay

Mean deviation of the initial wound size is 23 and final wound size is 2.38 with standard mean error of 1.374 and 0.330 respectively. Mean hospital stay is 29.30 with standard error of 1.405.

Mean wound size reduction in area is 20.62 with standard error of 1.043 and mean wound size reduction in percentage is 88.98 with standard error of 1.457.

Table 6 COMPARATIVE ANALYSES OF WOUND SIZE

In Wound Size-Initial, mean percentage of wound surface area is 23 with standard error of 1.374.and Wound Size-Final mean percentage surface area in 2.38 with standard error of 0.330. Mean difference of percentage of the wound surface area is 20.62. P value is 0.0471 which is significant.

Kovacs et al in 1998 ⁵ described about the use of vacuum assisted closure in the large skin defect caused due to the necrotising fasciitis. He also imposed about low contamination of wound with proliferation of healthy granulation tissue. In our study we also observe the proliferation of healthy granulation tissue and faster closure of wound with decreased hospital stay.

Morykwas et al ^[6] in 1997 conducted a series of animal studies deep circular defects of 2.5cm produced on back of pigs dressed with open cell polyurethane-ether foam pore size ranging from400-600nm.He described about the importance of the pore size which help in the acceleration of wound healing. he also described the efficacy of the wound healing using the negative pressure wound therapy. In our study also we used the foam pore size of 400 -600nm which helped in the accelerated wound healing and promoting the healthy granulation tissue proliferation. Moryk was et al^[6]also described about the importance of use of optimal pressure while doing negative pressure wound therapy. A series of Doppler study was done in different pressure while dressing with both intermittent and continuous pressure. And he came to the conclusion of use of 100 -125 mmhg pressure he observed a 4 times increase in blood flow than with increased pressure of400 mmhg which showed decreased blood flow. Hence in our study we proceeded with pressure of 125mmhg and showed promising results.

Philbeck et al suggested that intermittent/cycling application of pressure results in rhythmic perfusion of the tissue which is maintained. The cells which are undergoing mitosis must go through a cycle of rest for cellular component production and division. If the wound is subjected to continuous pressure the mitosis or cell division is reduced due to its continuity. Hence he suggested that intermittent pressure given at regular cyclic interval gave more promising result that the continuous type of pressure. So in our study VAC group we gave intermittent pressure of 125mmhg with 5 min cyclic interval showed good result.

Morykwas et al ^[7] toward the end of the study found out there is an increase in the flap survival rate of 21% when compared to the control flap. Moryk was & colleagues suggested the removal of interstitial fluid decreases localized edema and increases blood flow, which in turn decreases tissue bacterial levels and proposed that mechanical tissue deformation or stress within the tissue resulting in protein and matrix molecule synthesis and enhanced angiogenesis.

Negative pressure wound therapy (NPWT): Argenta and Morykwas determined that intermittent negative pressure at 125mmHg promoted wound healing by improving blood flow, granulation tissue growth rates and nutrient flow while reducing bacterial levels. Based on these findings, Kinetic Concepts (San Antonio, Texas) developed the VAC system. The VAC consists of a wound dressing (a charcoal-impregnated sponge-like material) connected by tubing to a wound canister, with a pump that creates negative pressure. A transparent drape or film over the dressing establishes the seal needed to create a vacuum. The pump can be adjusted for various levels of intermittent or continuous pressure. Exudate is collected in the canister.

When negative pressure is applied over the wound bed, the oedema fluid is evacuated along with all growth inhibiting factors. This relieves the back pressure effect on the healing tissues leading to improvement in local perfusion, local immunity, cellular waste disposal and tissue nutrition and oxygenation. Laser Doppler studies have shown there is a fourfold increase in the local perfusion at the wound site when the topical negative pressure is applied. Studies have shown that pressures below -400 mm of hg inhibit local blood flow. The most optimum negative pressure range is -25 to -200 mm of Hg.

The distribution of PUSH score at admission in the null hypothesis test retains the null hypothesis and distribution of PUSH score at the time of discharge rejects null hypothesis.

In our study we are comparing in the terms of PUSH score, wound size reduction in terms of surface area and percentage and duration of hospital stay at the time of admission and at the time of discharge.

In our study we are comparing in terms of PUSH score at the time of admission and at the time of discharge. Mean difference between the initial treatment and after treatment is 9.38 with standard error of Mean of 0.391.

When compared in wound size, initial wound size mean value of 23 with standard error in mean of 1.374. Wound size final mean value is 2.38. Mean difference between admission and discharge is 20.62 with P value 0.047 which is significant. This shows there is a significant difference in wound size between admission and discharge.

Mean reduction in surface area of the wound is 20.62 with standard error of 1.043 when compared with the reduction of wound size in term of percentage Mean percentage reduction of wound surface area is 88.98 with standard error of 1.457.

Mean hospital stay is 29.3 with standard error of 1.405.Thereby by this study done in 50 patients in which the efficacy of NPWT shows significant reduction in the wound surface area with the reduction of hospital stay

Patient were observed and documented with wound size reduction, proliferation of granulation tissue, exudate amount and duration of hospital stay. In this study we observed that marked reduction in wound size and surface area with shorter hospital stay. The time duration taken for formation of healthy granulation tissue was less. Granulation tissue formed was healthy and uniform. Hereby we conclude that the NPWT is effective in healing of the non- healing ulcers.

1. Silvis, R.S., Potter, L.E., Robinson, D.W., Hughes, W.F. (1955). The use of continuous suction negative pressure instead of pressure dressing. Ann Surg. 142(2): 252-6. Page no.27
2. Whelan C, Stewart J, Schwartz BF. (2005). Mechanics of wound healing and importance of Vacuum Assisted Closure in urology. J Urol. 2005 May; 173(5):1463-70.
3. Banwell PE. Topical negative pressure therapy in wound care. J Wound Care 1999; 8(2): 79-84.
4. FleischmannW,StreckerW,BombelliM,KinzlL.Vacuumsealingas treatment of soft tissue damage in open fractures].Unfallchirurg1993;96(9):488-92
5. Forozandeh F, Azizahari A, Abolhasani F, Larijani B. Neurologic and vascular assessment of foot in diabetic patients referred to diabetes clinic in Dr. Shariati hospital in 2003-4.Iranian J Diabetes Lipid.2005;(4):43– 51
6. Philbeck TE, Whittington KT, Millsap MH, Briones RB, Wight DG, Schroeder WJ. The clinical and cost effectiveness of externally applied negative pressure wound therapy in the treatment of wounds in home healthcareMedicarepatients.OstomyWoundManage1999;45(11):41-50.
7. Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum- assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann PlastSurg1997; 38(6): 553-62.