Bringing closure to chronic diabetic ulcers: Are vacuum assisted closure therapy, hyperbaric oxygen therapy or skin substitutes efficacious?

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1 Bringing closure to chronic diabetic ulcers: Are vacuum assisted closure therapy, hyperbaric oxygen therapy or skin substitutes efficacious? 1

2 Abstract Diabetic lower extremity ulcers are a devastating and expensive medical complication. Conventional treatments such as antibiotics, off-loading and debridement among others are often insufficient by themselves to treat chronic ulcers completely. Three adjunctive treatments: vacuum assisted closure (VAC) therapy, hyperbaric oxygen therapy (HBOT) and skin substitutes were compared to determine which therapy was most efficacious in the treatment of chronic diabetic ulcers. Current randomized trials suggest that HBOT has the most efficacy in the treatment of chronic ulcers. VAC therapy is efficacious before and after diabetic foot surgery. Whereas, skin substitutes have shown to heal ulcers at a faster rate, but lack current randomized trials. 2

3 Among the most common and costly complications of diabetes mellitus are lower extremity ulcers. Non-healing diabetic ulcers impede adequate perfusion and, if not treated effectively, eventually lead to amputation. The incidence of ulcer formation was 68.4 per 1,000 diabetic patients per year in Most ulcers form in the lower extremities. Adequate diabetes management and a multidisciplinary approach are necessary to prevent diabetic ulcers and amputations. Along with performing a vascular and diabetic foot exam at every diabetic patient visit, a clinician should educate their patient on ulcer prevention. Prevention strategies include having the patient examine their feet every day for any signs of injury or changes in skin color. Blood pressure, cholesterol, glucose and hemoglobin A1c levels among others should be maintained at target goals with medications, diet and lifestyle changes. Conventional treatments for diabetic ulcers include: controlling infection, off-loading using a cast, debridement and application of moist dressings. Conventional treatments may not be sufficient to heal chronic ulcers and adjunctive methods may be necessary. Three adjunctive treatments have been suggested as effective in the treatment of chronic diabetic ulcers: vacuum assisted closure (VAC) therapy, hyperbaric oxygen therapy (HBOT) and skin substitutes. Current research on these therapies base their evidence on small sample sizes and few randomized trials. Although more extensive research is necessary it is essential for providers to become knowledgeable with these therapies in order to offer diabetic patients the best chance of healing. The provider should understand which conventional treatments to implement and which adjunctive treatments: VAC therapy, HBOT or skin substitutes are most beneficial to the patient. Diabetic Foot Ulcers Callus formation on the foot may be the beginning sign of an ulcer. A callus may become moist with serous fluid underneath and the removal of the callus reveals an ulcer [See 3

4 Figure 1]. Diabetic ulcers are classified under three categories: neuropathic, ischemic and neuroischemic. Feet with neuropathic ulcers are dry with fissures and diminished sensation. Feet with ischemic ulcers are pale, cold and have an ankle brachial index (ABI) <1, whereas, feet with neuroischemia show both neuropathic and ischemic symptoms. Most foot ulcers develop from diabetic neuropathy. Conventional methods are indicated for ulcer treatment and vascular studies such as a duplex ultrasound and angiography are necessary if there is no indication of healing. 2 Conventional Treatments Medications The most important step in treating a diabetic ulcer is identifying an infection on clinical presentation. The provider must distinguish between contamination of a wound, colonization and infection. Topical agents serve to reduce colonization of the wound and are not indicated in the treatment of infection. These topical agents include: becaplermin gel and silver sulfadiazine among others. Infection can be localized to the ulcer or be so extensive it turns into gangrene. Signs of an infection include the presence of granulation tissue, discoloration, discharge and foul odor. 2 Off-loading Off-loading is an intervention that decreases the pressure placed on an ulcer. The gold standard for off-loading a diabetic foot ulcer is a total contact cast (TCC), which is intended to redistribute the weight placed on the foot. If TCCs are not correctly applied, new ulcers may form, therefore an experienced cast technician or provider should apply the cast. A study in 2005 discussing the use of casts for diabetic ulcers found that 89% of patients achieved healing 4

5 by 5 weeks with the use of TCCs with only minor complications. 3 Contraindications to TCCs include deep wounds, osteomyelitis or an ABI < Debridement Debridement prevents the formation of peri-wound pressure and reduces the likelihood of infection allowing for better wound healing. Types of debridement include: surgical, hydrogels, enzymatic, biological and chemical. 5 The use of maggots to treat diabetic ulcers is a biological type of debridement; although an acceptable method in Europe it is rarely used in the United States. Advanced moist wound therapy (AMWT) Several types of moist dressings can be used to treat diabetic ulcers. Moist dressings with collagen alginate combinations and carboxymethylcellulose are best used on ulcers with a large amount of exudate, whereas hydrocolloid dressings are better for ulcers with little exudate. 5 Other An ancient method of healing is the use of honey on non-healing wounds. The topical application of honey on diabetic ulcers has been suggested as a cost-effective method for treatment of chronic diabetic ulcers. Bacteria have been found to be non-resistant to honey thereby minimizing infection. 6 Few randomized trials exist and more extensive research is needed on the use of honey in the treatment of diabetic ulcers. How adjunctive therapies work VAC therapy was first introduced in 1996 as a method to aid in the healing of chronic wounds. The equipment consists of a foam dressing cut to size and placed on top of the wound, a track pad that connects to a drainage tube and a small device that transmits negative pressure to the wound. An adhesive covering attaches the foam to the patient s limb and a canister collects 5

6 the wound exudate. VAC therapy promotes granulation tissue by two methods: macrostrain and microstrain. Macrostrain compresses the foam dressing through negative pressure. This method allows for wound edges to come together, removes exudate and infectious material. Microstrain occurs at the cellular level decreasing inflammation and increasing perfusion. 7 Before VAC therapy is started, debridement and limb revascularization may be necessary to enhance the healing process. Contraindications to VAC therapy include infection and osteomyelitis among others. The VAC device attaches to the patient whereas HBOT is administered in a pressurized chamber. While in the pressurized chamber, a patient inhales 100% oxygen. Most non-healing wounds are hypoxic and HBOT works by delivering oxygen to promote healing. Medical personnel monitor the patient s progress and special equipment verifies the amount of oxygen delivered to the wound before and after treatment. Among the side effects of HBOT are ear fullness and rarely oxygen toxicity and visual changes. Contraindications to HBOT include thyrotoxicosis, obstructive lung disease and malignancy. The most innovative treatment for diabetic ulcers are skin substitutes including fibroblast derived dermal substitute and graftskin composed of both epidermal and dermal skin. How fibroblast derived dermal substitute and graftskin work is not understood completely, but it is thought that both methods provide matrix components that stimulate angiogenesis. The most common adverse effect of skin substitutes is an immune response from the host leading to rejection. Contraindications include infected or cancerous skin. Efficacy VAC therapy 6

7 VAC therapy is demonstrated to heal wounds in a shorter amount of time compared to conventional therapies after partial diabetic foot amputations. In a 2005 randomized controlled study participants were required to have adequate perfusion to the affected limb. Adequate perfusion was defined as having a transcutaneous oxygen measurement on the dorsum of the foot > 30 mmhg, ABI 0.7 and 1.2, and toe pressure 30 mmhg. The VAC therapy group had their dressings changed every 48-hours while the conventional therapy group was treated with moist wound dressings that were changed daily. Off-loading was implemented in both treatment groups. The results showed that the VAC therapy group (n = 77) had 56% of wounds heal in comparison to 39% in the conventional therapy group (n = 85). The median time for complete closure was 56 days in the VAC therapy group compared to 77 days in the conventional therapy group (p = 0.005). 8 A shorter duration of healing time was also shown when using VAC therapy to treat chronic wounds. In a 2007 prospective study, VAC therapy is shown to be an effective intermediate therapy after debridement and before surgical intervention. VAC therapy was used on 29 participants and another 25 participants were treated with gauze therapy. After treatment the wounds were surgically closed. The VAC therapy group started showing healing at a minimum of 6 days in comparison to 10 days in the gauze therapy group. Also, the reduction in surface area was greater in the VAC therapy group in comparison to the gauze therapy group (p < 0.05). 9 The study emphasized that VAC therapy allows for less dressing changes, one every 48 hours, in comparison to two times or more every 24 hours in the gauze therapy group. However, participants were not equally distributed within the two treatment groups. The VAC therapy group had a larger number of participants that were diabetic in comparison with a larger amount of spinal cord injuries in the gauze therapy group. Also, the study was not double- 7

8 blinded because wounds treated with VAC therapy had suction marks after the removal of the device, making it obvious which participants were treated with VAC therapy. VAC therapy was suggested to be more efficacious than AMWT in the treatment of diabetic foot ulcers. In a 2008 randomized controlled study, participants were treated for 112 days with either VAC therapy or AMWT. The results showed that 73 of 169 participants (43.2%) treated with VAC therapy achieved complete closure in comparison with 48 of 166 participants (28.9%) treated with AMWT. 10 The Institute for Evidence-based Medicine commented on the study after its publication, citing several flaws in the interpretation of data. Among the critiques: lack of a blinded committee, participants withdrawn from the study without a stated reason and no data demonstrating complete closure at 3 and 9 months follow-up. 11 In response to the critique, the authors emphasized the difficulty in conducting a blinded study on VAC therapy and claimed the data was gathered objectively. Similarly, a 2010 prospective trial also suggests that VAC therapy is effective in closing ulcers. An orthopedic department saw the participants in the study from for their diabetic ulcers. The study included 11 diabetic patients treated with VAC therapy for an average of 23.3 days. Pressure was applied by VAC therapy either continuously or intermittently, on for 5-minutes and off for 2-minutes, at -75, -125 or -150 mmhg and dressings were changed an average of 14 times. All participants, except for one that underwent two debridement procedures, achieved reduction in ulcer size. After VAC therapy, wounds were closed by splitgraft and two wounds by secondary closure. Although the study demonstrates that VAC therapy is successful in closing ulcers, the decrease in ulcer size was not statistically significant (p > 0.05). 12 HBOT 8

9 The efficacy of HBOT in treating diabetic foot ulcers is suggested in a 2008 prospective study. The 45 participants in the study were treated with HBOT from May 2005 to March They were treated with 100% oxygen at 2.5 atmospheres absolute for 5 days a week. Success was defined as a wound that had 80% or more granulation tissue after completing an average of 20 sessions of treatment. The study found that 32 participants (71%) achieved complete closure of their ulcers. 13 HBOT worked for most diabetic foot ulcers, but there was no evidence to show that it was better than other therapies until a double-blinded control study in In the study all participants had a below the ankle non-healing ulcer for more than 3 months. Participants treated with HBOT were given 40 sessions of treatment for 8 weeks. The control group was treated with hyperbaric air for the same amount of time. Patients were followed after 1 year and it was found that 52% (25 of 48 participants) treated with HBOT versus 29% (12 of 42 participants) in the control group achieved complete healing. 14 This study has the most evidence to suggest the efficacy of HBOT. Previous studies examining the efficacy of HBOT were non-randomized and were not double-blinded. However, the study has limitations, only 55% of the participants in the study were followed after one year. 15 Skin substitutes In 2001 a randomized controlled study demonstrated that graftskin has a faster rate of healing than conventional therapies. Although the study is outdated it deserves recognition as being one of the few trials to study the effectiveness of graftskin on non-infected diabetic ulcers in comparison to conventional therapies. In the study 112 participants were treated with graftskin and 96 treated with moist dressings. Patients were treated for a period of 12 weeks. The diabetic ulcers selected for treatment were to be non-healing for at least 2 weeks and 9

10 between 1-16 cm 2 in size. Results demonstrated healing in 63 (56%) participants treated with graftskin in comparison to 36 participants (38%) treated with moist dressings. 16 Graftskin was applied an average of 3.9 times during the length of the study while moist dressings were applied twice a day. The study notes that the weekly application of graftskin for at least four weeks shows healing at a faster rate than standard therapies. Fibroblast derived dermal substitute, is also suggested to expedite the healing process of ulcers. In a 2003 study fibroblast derived dermal substitute was compared to conventional therapies in the treatment of non-healing ulcers. Conventional therapies included: debridement, off-loading and moist dressings. The intervention group was treated with a dermal substitute and conventional therapies. After 12 weeks complete healing was achieved in 30% of the patients treated with a dermal substitute and conventional therapies in comparison to 18% in the group only treated with conventional therapies. Adverse events such as infection, osteomyelitis and cellulitis were lower in patients treated with a dermal substitute (p = 0.007). Also, 8% (13 of 63) of participants treated with a dermal substitute needed surgical treatment in comparison to 15% (22 of 151) in participants only treated with conventional therapies. 17 Comparing efficacy of adjunctive treatments The greatest challenge encountered with VAC therapy is patient non-compliance. If patients disconnect the VAC device and the dressing is not changed frequently the wound accumulates exudate making the possibility of infection more likely. This will exacerbate the patient s condition and increase the time spent at the hospital. A good candidate for VAC therapy is a compliant patient with adequate diabetes control who has been educated on the proper use of the device. From the three adjunctive therapies discussed VAC therapy may be a first option for most patients for the mere fact that it is more readily available, especially for 10

11 patients living beyond reasonable traveling distance of HBOT locations. A patient is able to use a VAC device at home and is not inconvenienced by the frequent sessions required for HBOT. The randomized control study of 2005 and the prospective study of 2007 demonstrate that VAC therapy is efficacious before and after surgery on a diabetic foot. However, the 2007 prospective study was not geared toward just diabetic ulcers, but toward full-thickness wounds in general. The study has one major limitation: participants were not equally represented in either group because the intervention group had more diabetic patients than the control group. The 2008 study comparing VAC therapy to AMWT was not blinded and lacks follow-up data. Similarly, no statistical significance was shown on ulcer size reduction in the 2010 study comparing VAC therapy and conventional therapies. Although VAC therapy is more readily available it has a greater chance of malfunction if not appropriately used, this makes HBOT a more reliable method in comparison to VAC therapy. HBOT is monitored by medical personnel while patients receive therapy. Furthermore, several studies conducted on VAC therapy have limitations and sample sizes are too small to make any conclusions regarding its efficacy. The efficacy of HBOT in comparison to conventional treatments was well demonstrated statistically in the 2010 randomized trial. However, both the 2010 study and the prospective study of 2008 are limited in their interpretation of data because the sample sizes are small (< 100 participants). Few randomized controlled studies have been done on fibroblast derived dermal substitutes and graftskin. The 2001 and 2003 randomized controlled trials comparing skin substitutes to conventional treatments demonstrate that skin substitutes have a faster rate of healing than conventional treatments alone. 11

12 Future randomized trials should be double-blinded, sample sizes large, patients should be followed after treatment and have an objective committee to analyze the results. The costeffectiveness of VAC devices, HBOT and skin substitutes is yet to be determined as there have not been studies to compare their economic impact and costs may vary from one patient to another. Advice for Clinicians Treating diabetic ulcers is not the sole responsibility of one provider, but it is a multidisciplinary approach including family medicine, podiatry, orthopedics and vascular surgery among others. Knowing when to refer to the appropriate specialty is just as important as a diabetic foot exam at every visit. A non-infected ulcer is most appropriately treated with offloading devices and moist dressings. If the ulcer is non-healing for over a month then the addition of adjunctive measures may be implemented to aid in healing. Although the patient may be limited on their treatment options based on insurance coverage, the provider should consider all adjunctive treatments that would be most beneficial to the patient. Inevitably a provider will encounter diabetic patients with non-healing ulcers in their practice. Future studies may give the clinician more answers making the process more manageable and cost-effective. The goal of therapy is to implement effective adjunctive methods that minimize the significant cost of treating diabetic ulcers, avoid amputation and facilitate complete healing. Implementing adjunctive measures such as: VAC therapy, HBOT or skin substitutes may be worth the heavy cost of amputations. Furthermore, the psychological impact of depression and anxiety that comes with amputations and long hospital stays are considerably decreased if any of the three methods are used to achieve a successful outcome. These adjunctive measures may be valuable in bringing closure to chronic diabetic ulcers. 12

13 References: 1. Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non- Hispanic whites from a diabetes disease management cohort. Diabetes Care. 2003;26(5): Edmonds ME. ABC of wound healing: diabetic foot ulcers. BMJ. 2006;332(7538): Nabuurs-franssein MH, Huijberts MSP, Sleepers R, Shaper NC. Casting of recurrent diabetic foot ulcers. Diabetes Care. 2005;28(6): Martin N, Oldani T, Claxton MJ. A guide to offloading the diabetic foot. Podiatry Today. 2005;18(9): Mulder G, Armstrong D, Seaman S. Standard, appropriate, and advanced care and medicallegal considerations: part one diabetic foot ulcerations. Wounds. 2003;15(4): Eddy JJ, Gideonsen MD. Topical honey for diabetic foot ulcers. J Fam Pract. 2005;54(10): Understanding the science behind VAC therapy [Internet]. United States: Kinetic Concepts, Inc.; c [cited 2010 Feb 14]. Available from: 8. Armstrong DG, Lavery LA. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomized controlled trial. Lancet. 2005;366: Mouës CM, Van den Bed GJ, Leule F, Hovius SE. Comparing conventional gauze therapy to vacuum assisted closure wound therapy: a prospective randomized trial. J Plast Reconstruct Aesthete Surg. 2007;60(6):

14 10. Blume PA, Walters J, Payne W, Ayala J, Lantos J. Comparison of negative wound therapy using vacuum assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. Diabetes Care. 2008:31(4): Hemkens LG, Weltering A. Comparison of negative pressure wound therapy using vacuumassisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial: response to Blame et al. Diabetes Care. 2008;31(10):e76-e Nather A, Chionh SB, Han AY, Chan PP, Nambiar A. Effectiveness of vacuum-assisted closure (VAC) therapy in the healing of chronic diabetic foot ulcers. Ann Accad Med Singapore. 2010;39(5): Ong M. Hyperbaric oxygen therapy in the management of diabetic lower limb wounds. Singapore Med J. 2008;49(2): Löndahl M, Katzman, P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care. 2010;33(5): Lipsky BA, Berendt AR. Hyperbaric oxygen therapy for diabetic foot wounds: has hope hurdled hype? Diabetes Care. 2010;33(5): Veves A, Falanga V, Armstrong DG, Sabolinski ML. Graftskin, a human skin equivalent, is effective in the management of non-infected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001;24(2): Marston WA, Hanft J, Norwood P, Pollak R. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003;26(6):

15 Figure 1. Diabetic right foot ulcer of the plantar surface 15

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