Turning Evidence Into Practice: A Guide To Treating Chronic Wounds In The Diabetic Foot
This is similar to Regranex in that this is a gel containing only one growth factor, platelet derived growth factor (PDGF) beta. It does have Level 1 evidence as randomized clinical trials also had to be performed prior to approval by the FDA for diabetic foot ulcers.
As for the other “tissue substitutes,” Oasis (Healthpoint), Integra (Integra Life Sciences) and Graft Jacket (Wright Medical) are all nonliving acellular wound products and are most often classified as wound coverings. When I see the word acellular, I start to wonder what these products provide other than a covering that can prevent the wound from becoming colonized or infected. However, these products cannot deliver the growth factors and cells that are either missing or lacking activity in a patient with diabetes or with edema due to venous reflux/congestion.
In regard to Orcel (Ortec International), a living bilayered cellular matrix, while it has an indication for donor site wounds in burn patients, the modality does not have FDA indications for diabetic or venous stasis ulcers.
Based on this information and my goal of putting into practice evidence-based medical decision making and treatment protocols, Apligraf is the clear cut answer to my question of how to close the nonhealing wound in the shortest amount of time.
Does The Evidence Support Other Commonly Used Wound Care Modalities?
Offloading is also an important factor. Again, the evidence suggests that either total contact casting or the instant total contact cast, as described by Armstrong and Lavery, is my answer for patients who want to ambulate to some degree.7 Otherwise, the use of a wheelchair and complete non-weightbearing is an option but one that is often not the best for most of my patients who continue to lead active lives.
I have not discussed dressings for the wound. There is no significant evidence available from manufacturers or in the literature on wound dressings and their efficacy. Moist wound healing, as researchers showed during the Regranex (Johnson and Johnson) clinical trials, provides the optimum environment for wound healing.
Platelet concentrates have been a hot topic again in the wound healing arena. As of this date, concentrates are not FDA approved for wound healing indications. There is at least one ongoing clinical trial looking into this technology. In the past, there was not enough evidence that platelet concentrates improved wound healing. Accordingly, the technology is not covered as it is currently seen as experimental by most insurance plans.
There is evidence to support the use of negative pressure wound therapy (NPWT), which is indicated for deeper and larger wounds as well as to help control edema. It is not intended to take the wound from a large defect to complete epithelialization. I often use VAC therapy (KCI) for a few days to a few weeks to fill in areas of large defect.
Emphasizing The Value Of Electronic Health Records
In regard to the treatments I discussed above, they are documented within the EHR. Accordingly, I can query the database to look at the outcomes of my patients based on the treatment, diagnosis, rate of wound healing and time to healing. I also use my EHR to follow my patient once the wound is healed by using Practice Health Maintenance (PHM), a component of the EHR.
I also take digital photographs of all wounds I treat before and after debridement. I then use computer software (PictZar) to document the size (length, width, area and circumference of the wound) and depth of the wound. The software allows me to measure the necrotic and or fibrotic tissue present in the wound, and follow the progression of the wound. One may also use the software to show improvement over time in either graphical or table formats. This software also is linked to the EHR, which allows one to have a complete medical record in one place. Using this electronic method of measuring improves the accuracy of measurements as well.
Once the wound is healed, and if indicated, I may fabricate custom orthotics to offload bony prominences or dispense extra depth shoes and insoles. I may also do follow-up ABI and toe pressure measurements after the vascular intervention depending on my relationship with the interventionalist.