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PIC AND STUDY RESULTS ..



HEALING DIABETIC ULCERS with Viabecline, a new topical antibiotic ointment By Christopher Otiko DPM

Dec 1, 201649 views


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ABSTRACT in brief

BACKGROUND

Diabetes affects almost a half a billion people globally with 23 million affected in the US. With about 83 million affected with condition designated as pre-diabetes. Of those with diabetes, 50% will develop peripheral neuropathy and/or diabetic ulcers. Of the 23 million people affected with diabetes, 25% will develop diabetic ulcers many will require expensive therapy or invasive surgical amputations.

OBJECTIVE

The goal of this study was to evaluate the efficacy and safety of FDA registered OTC Viabecline tetracycline hydrochloride. A topically applied antibiotic ointment designed for the treatment of diabetic foot ulceration.

RESEARCH DESIGN AND METHODS

Clinical investigation (CI) documenting the treatment effectiveness was estimated by enrolling consecutive patients in a multi-center outpatient clinic setting.

RESULTS

Viabecline was more effective than standard care, including IV antibiotics. The effect was greatest in those with the most severe wounds, i.e., large wounds that affect deeper anatomical structures. These patients were last resort patients that had failed all previous care and were headed to an amputation. In some cases even an amputation wasn’t feasible because of the patient’s cardiac status.

CONCLUSIONS

Viabecline is more than 96% effective in healing diabetic foot ulcers within 4 weeks. This effect is more pronounced in more severe wound, and the effect is the same whether the wound is infected or not.





BACKGROUND

Diabetes affects almost a half a billion people globally with 23 million affected in the US [2]. With about 83 million affected with condition designated as “pre-diabetes.”[3] Of those with diabetes, 50% will develop peripheral neuropathy and/or diabetic ulcers. [4] Of the 23 million people affected with diabetes, 25% will develop diabetic ulcers many will require expensive therapy or invasive surgical amputations [5].These wounds are often multifactorial in origin, but tend to occur on the plantar surface of the foot and arise in the setting of peripheral neuropathy, vascular compromise or both. Diabetic foot ulcers are associated with increased morbidity and mortality, and they have a negative impact on both the quality of life and the productivity of diabetic patients [6]. Almost 80,000 people (US) will require lower extremity amputations (LEAs) every year. Of those who require amputations, and depending on which study you choose, one year mortality rates of 10 to 50 percent, and the 5-year mortality rate post-LEA is between 30 and 80 percent.[7-12] Costing about $245 billion in 2012 and cost $365 billion in 2016 [13-15]

OBJECTIVE

The goal of this study was to evaluate the efficacy and safety of FDA registered Viabecline, tetracycline hydrochloride, a new topical antibiotic ointment. [16] Viabecline is a topically applied antibiotic designed for the treatment of diabetic foot ulceration as well as for other basic wound care needs.

RESEARCH DESIGN AND METHODOLOGY

Given the degree of severity of the patient’s condition(s) they were treated consecutively utilizing the multicenter approach. The majority of the patients were treated at Dr. Christopher Otiko practice and at various hospitals and rehab centers in Southern California.

Briefly, subjects were chosen for this study if they were patients with confirmed diabetes who had an ulcer on their foot. Additionally, 90% of these patients were “last resort” patients. Those selected to participate were patients who had failed all previous care and were headed for an amputation or had a non-healing wound for more than 6 months. In some cases even an amputation was problematic because of the patient’s cardiac status.

The wounds were classified using The Wagner-Meggitt classification is based mainly on wound depth and consists of 6 wound grades.[17] These include: grade 0 (intact skin), grade 1

(superficial ulcer), grade 2 (deep ulcer to tendon, bone, or joint), grade 3 (deep ulcer with abscess or osteomyelitis), grade 4 (forefoot gangrene), and grade 5 (whole foot gangrene) APPLICATION

Viabecline Protocol: One or two drops externally applied topical solution directly to the ulcer and rubbed into skin for 30 seconds three times daily. Ulcer was covered with non-sterile gauze dressing.

Patient data

Sex Male: 12. Female: 16

Average Age (years) 69.5

Wound area (cm2) average 1.89

Wound duration (weeks) 16

Wound grade 2.01?(1.98–2.04)

Diabetes type T1/8 – T2/20

Insulin dependent 6

Non-insulin dependent 22

Infected 8



CLINICAL OUTCOMES Study end point

We used an end point of 20 weeks for assessing whether a patient healed. However, 27 out of 28 patients healed within 4 weeks.

One patient who had an exposed necrotic extensor tendon took the longest; 12 weeks. He also had end stage renal disease and peripheral vascular disease which attributed to the delayed healing. Because we wanted to ensure adequate follow up we extended the treatment time to at least 12 weeks, our actual end point was a healed wound within the subsequent 4 weeks. We did this to be consistent with other studies on the efficacy of diabetic foot ulceration therapy. Many of these studies treated patients who had already failed to heal with standard therapy with an investigational agent for 20 weeks



CLINICAL OUTCOMES Study end point (continued)

Of the 28 patients in this study, 100% were treated with Viabeclne and healed by the 12th week of care Patients treated were more likely to have larger wounds, older wounds, and wounds of higher grade. Overall, 27 out of 28 patients (96% of patients) healed within 4 weeks of the initiation of care. The patient had an exposed necrotic extensor tendon took the longest to heal (12 weeks). The patient also had end stage renal disease and peripheral vascular disease which attributed to the delayed healing. His treatment continued at home where his daughter who was a Certified Nurse’s assistant (CNA) applied Viabecline 3 times daily until his ulcer healed in a total time of 12 weeks.

CONCLUSION

This study is the first independent assessment of the efficacy of Viabecline in the treatment of diabetic foot ulcers. We found that Viabecline is very effective in the treatment of diabetic foot ulceration. It appears that Viabecline can be used in minor wounds, but possibly, is more likely to be used in more severe wounds and may be more effective than standard care for severe wounds.

Most patients treated with Viabecline did not begin this treatment until the 3rd month with the ulcer and the Viabecline was the last resort. One patient had a confirmed diagnosis of MRSA that had not responded to 6 weeks IV Vancomycin treatment. Previous studies that examined the efficacy of treatments for diabetic foot ulceration have often used the cutoff of twenty (20) weeks of care. Our study revealed that we achieved healing after only 4 weeks of treatment. We used 20 weeks of care as our study end point. Viabecline treatment typically ended after only 4 weeks on average. Patients in our study had a four (4) week treatment period and a total 20-week observation follow up period. This is consistent with our in house pre-CI that suggests that most infections are under control in about a week and near complete wound recovery in four (4) to six (6) weeks. Previous established therapeutic strategies [18] could take up to twenty weeks (20) then the percentage of healed diabetic neuropathic foot ulceration levels off after approximately five (5) months. This indicates very little increased healing after the 20 week mark. Whereas 96% of our patients all healed within 4 weeks using Viabecline one (1) to three (3) times daily depending on the condition of the patient.

We found that Viabecline healed 96% diabetic neuropathic foot ulcers after 4 weeks of care when compared with treatment using standard care alone. The relative benefits of Viabecline over standard care persist for wounds of all sizes (with or without and infections) and the relative risk of healing using Viabecline versus standard care increases with wounds that are larger and more severe. In the setting of this study, these were also the patients more likely to be treated with Viabecline. Therefore, Viabecline represents an effective treatment for diabetic foot ulceration. Viabecline also appears to be effective in severe wounds, and may therefore play an important role in preventing amputation