New treatment protocol can avoid amputation
October 1, 1997
New treatment protocol can avoid amputation
Success reported with six diabetics
By Lawrence O. Kollenberg, DPM
Medical Director
Garland County Foot Clinic
Hot Springs, AR
Wound infections lead to complications such as delayed healing, exacerbation of diabetes mellitus, and potential for loss of a digit or limb. Some reports in the literature show that a collagen sponge can be used as a delivery vehicle for other products.1-3 The cost of an amputation routinely exceeds $40,000,4,5 and the psychosocial ramifications associated with amputation are tremendous. Who can place a true cost on such devastating complications?
It is a well-known fact that as blood flow decreases, the potential for infection and loss of limb rises. Through impregnation of with three different antibiotics, I have been able to stave off digital and leg amputations in six diabetic patients, all of whom had confirmed osteomyelitis as determined via bone tissue biopsy. This article will share the methods of care applied to these six patients, detailing the specific protocol for combating infectious disease.
A total of six patients, all insulin-dependent diabetics, presented at different times with infected diabetic ulcerations at the Garland County Foot Clinic in Hot Springs, AR. All six patients were 70 years of age or older. During the course of the histories and physical examinations, all patients were noted to have diminished vascular status including non-palpable or decreased-palpable pedal pulses, delayed capillary fill time, positive findings for diabetic peripheral neuropathy, ulcers of varying size (3.0 cubic centimeters or greater). All six lesions were clinically grossly infected with significant cellulitis, erythema, and purulent drainage, and all emitted a strong odor.
Pathomechanical evaluation of neurotrophic diabetic feet did reveal additional orthopedic deformities that were present in all six cases. Clinically, all six patients were able to be probed to bone, and plain radiographic evaluation revealed significant osteomyelitis changes in each case. Blood lab analysis included a complete blood cell count with differential; random blood sugar; total proteins; albumin, globulin, and albumin-globulin ratio; C reactive protein; sedimentation rate; serum creatinine; and blood urea nitrogen.
In addition, all patients were known to be on insulin; four were taking split dosing insulin twice daily. All patients had access to home glucometers. None of the patients were bypassable, and each had an ankle brachial index of less than 0.5. All cases were followed to complete closure and wound epithelialization.
All wounds initially were depressurized with application of felt, foam, or additional appliances to extend pressure directly off of the wound site. All patients were placed into an open-toed Darco surgical shoe. In five of six cases where cellulitis to popliteal or inguinal nodes were found to be present, warm, moist compresses were applied for two to five days to assist with controlling cellulitis on a homebound basis. No hospital admissions or intravenous antibiotics were required. Four of six patients were assisted by home health nurses during the course of dressing changes. Long-term management for all cases did include biomechanical stabilizing and restoration to normal conventional shoe gear orthotics after wound epithelialization.
The procedures
All patients were surgically debrided. At the time of initial debridement, bone biopsy of infected bone was obtained, and curettage of bone was performed. Initially, all six patients’ osteomyelitis lesions were impregnated with gentamycin (10 mg/cc of mature lyophilized type I bovine collagen particles) and dressed with Ex-U-Dry and a secondary dressing. Gauze incorporation of buttress pads on digital lesions was performed. Upon receipt of a culture report, three patients remained on gentamycin, two were changed to clindamycin (60 mg of clindamycin per cc of mature Lyophilized type I bovine collagen particles), and one patient received vancomycin (66 mg/per cc of mature Lyophilized type I bovine collagen) applied to the infected site.
All patients were seen at the Garland Clinic 48 hours post biopsy and again 72 hours afterward. Two patients were seen twice weekly for two additional weeks. The other four were reduced to once-weekly visits. In all cases, wounds were measured for three-dimensional size and appearance. They were assessed clinically for response to infection.
Co-management of diabetes was conducted with each patient’s regular attending physician. No amputations were performed. Post-ulceration follow-up no ranges from three to 15 months.
Ipsen et. al. reported drawing measuring serum levels after the implantation of collagen sponges impregnated with gentamycin, noting that those levels ranged from 0.0 to 0.04 mcg/cc, which are subtherapeutic levels.3 Chvapil reports that collagen material can function as a drug delivery vehicle.1
I have been is unable to detect any gentamycin or vancomycin in the blood during periodic post- treatment analyses. Thus, the results of this study strongly suggest an alternative to amputation in patients with poor vascular perfusion, which can be accomplished by controlling the infection with topical application of mature lyophilized type I bovine collagen particles in combination with antibiotics mixed directly into the collagen particles. Although additional work must be done with this combination of materials, it does show significant promise for alternatives to amputation in infected osteomyelitis diabetic ulcers.