Examining The Potential Of Collagen Powders In The Diabetic Foot

While collagen powders are not new to the market, they have recently become among the more commonly used advanced wound care products, especially among podiatric physicians. As more physicians and wound care specialists are looking for more rapid and economical alternatives to enhance wound healing, collagen powders can be extremely effective.

Needless to say, what you take off a wound (debridement) is still more important than what you put on it. Proper wound debridement, offloading and moisture balance remain critical no matter what you put on a wound.¹ Certainly, maintaining a debris-free wound is still key to wound healing. While the most obvious benefits of collagen powder are the ease of use and cost, the powder form of a collagen protein has immediate bioavailability for the wound bed, thereby enhancing wound healing.

In addition to immediate bioavailability, collagen powder allows for greater diffusion over the surface of the wound bed. Enhanced wound contact and bioavailability stimulate the body’s own tissue repair. A more recent understanding of the natural shape and function of collagen in wound healing has helped practitioners be more educated about their wound healing options.  

Among patients with diabetes and wounds, we know that type 1 collagen is in deficit along with normal fibroblast proliferation.² Overall, we can say with some confidence that collagen enhances the wound contracture and cellular migration that are essential for wound healing.^3,4

Type 1 collagen is essential for the release of growth factors by the extracellular matrix, which also serves to store and protect growth factors. However, when the extracellular matrix is disrupted, loss of tissue and bacterial overgrowth can occur.⁵

As integrin interaction with collagen influences the ability of macrophages, fibroblasts and endothelial cells to migrate and attach themselves, type 1 collagen in turn becomes essential in order to recruit macrophages and monocytes. Interestingly, this chemotaxis process is concentration dependent, meaning the more collagen, the stronger the stimulus.⁶

Collagen breakdown occurs naturally as the result of metalloproteases like collagenase or through some other type of trauma or enzymatic erosion. However, when this process occurs, these collagen fragments stimulate the infiltration of macrophages and fibroblasts in the wound bed. Moreover, the body recycles leftover exposed amino acids from this fragmentation process and uses them for the production of new proteins for enhanced wound healing.

In theory, the laboratory fragmentation of collagen will result in the creation of more active sites in the wound for the binding of fibronectin and improved fibroblast viability.

Collagen fragments in the form of a collagen powder created as the result of hydrolyzation or some other patented process will in the same fashion improve fibroblast viability and cellular response to stress, and better modulate protease activity. Accordingly, these collagen fragments will serve to guide fibroblasts along the connective tissue matrix to achieve better wound healing.

While all collagen powders undergo some fragmentation process for the aforementioned purposes, the way in which fragmentation occurs differs among available products on the market. Most collagen powder products on the market “fragment” their collagen using a hydrolyzation process. These products include Stimulen (Southwest Technologies) and CellerateRx (Wound Care Innovations).

Non-hydrolyzed collagen products retain significantly more native triple helical protein structure, thereby allowing for better stability of the molecule and scaffolding in wound healing. The main purposes of collagen in wound healing are providing integrity and structure to the wound. When the collagen molecule is fragmented (losing its natural triple helix shape), its role shifts to more of a reparative role through its chemotactic properties (activation of monocytes, thus creating more macrophages, etc.).

The vital importance of collagen as a scaffold for wound healing lies in its ability to retain its triple helix shape, which enhances thermal stability, mechanical strength and the ability to engage in specific interactions with other biomolecules. While I have already discussed the benefits of collagen fragments for chemotaxis and fibroblast proliferation, it should be the goal of any collagen wound product to retain as much of its natural triple helix shape as possible.

Collagen powders on the market that retain some of this natural triple helix structure (Helix 3-CP, Amerx Health Care) may enable better scaffolding and cell migration for the creation of granulation tissue.
Without question, collagen-based wound dressings are ideal for chronic wounds by addressing elevated levels of matrix metalloproteinases (MMPs), which degrade both viable and non-viable collagen.
Without the proper formation of the scaffold needed for cell migration, the formation of the extracellular matrix and granulation tissue will be significantly altered. Collagen-based dressings also have the ability to absorb excess wound exudate while maintaining a moist environment for wound healing.⁸

Billing Pearls For Collagen Powders
Medicare reimburses collagen powders with the code A6010. Products like collagen powders have coverage when they meet either of the following criteria:

1. They are required for the treatment of a wound caused by or treated by a surgical procedure; or
2. They are required after debridement of a full-thickness wound.

Surgical dressing codes require the use of modifiers A1-A9 (A1 = one wound; A2 = two wounds, etc.). One may dispense up to 30 units (one unit = 1 gram) per wound every 30 days as needed. As physicians send any wound dressing being billed to insurance home with the patient, claims submitted to the durable medical equipment regional carrier (DMERC) will use the place of service code (POS=12) corresponding to the patient’s residence. Do not use the place of service office code (POS=11). Additionally, patients who are under any home health status (even services not related to the wound) are not eligible for the billing of wound care products to DMERC. Medicare will deny claims for wound care-related dressings (even compression garments) if the patient is still under any home health designation. It is always wise to confirm the patient’s status before billing wound dressings.

Dressing size and quantity must be based on and appropriate to the size of the wound. Dressing needs may change frequently (e.g., weekly/daily) in the early phases of wound treatment and/or with heavily draining wounds. Suppliers are also expected to have a mechanism for determining the quantity of dressings that the patient is actually using and to adjust their provision of dressings accordingly. One may provide no more than a one-month supply of dressings at one time unless there is documentation to support the necessity of greater quantities in the home setting in an individual case. An even smaller quantity may be appropriate.

One must tailor surgical dressings to the specific needs of an individual patient. When surgical dressings come in kits, Medicare covers only those components of the kit that meet the definition of a surgical dressing that the physician orders and those that are medically necessary.

(Disclaimer: This information does not guarantee reimbursement but provides guidance for accurate documentation and appropriate usage for collagen wound care supplies. Should you need further technical assistance or have specific coding questions, please contact your DMERC or other intermediary.)

How To Apply Collagen Powders
As most collagen powders come in sterile packages, it is only natural for some physicians to attempt to “sprinkle” the powder over the wound in order to achieve the proper application. While this may work in some situations, it can often be difficult to administer adequate amounts of the product on the target site without creating waste.

My preferred method of application entails the utilization of a sterile tongue depressor for ease of applications and reduction of waste. Use the tongue depressor to gather a small scoop of powder on its flat edge. Then transport the powder to the wound edge and apply it by rotating the depressor directly to the wound site. The collagen will immediately begin to absorb the wound fluids as it adheres to the site. Ideal results will occur if there is adequate powder to fill the wound and when the area is moist to facilitate incorporation of the collagen into the wound.

Supplementing the wound site with sterile saline or some other type of hydrogel is appropriate as long as there is not excessive moisture, and as long as one does not wash or flush the powder out of the wound.

Case Study: How The Use Of Collagen Powder Helped Heal A Diabetic Neuropathic Ulcer
A 55-year-old patient with diabetic neuropathy, deformity and significant contracture of his digits presented with a Grade 2 diabetic ulcer as a result of poor fitting shoes. After a comprehensive diabetic foot exam and X-rays (revealing no osteomyelitis), I debrided the wound, flushed it and applied Helix 3 Collagen Powder (Helix 3-CP) to the wound bed followed by a 2x2 gauze pad and Coban.

The wound was adequately moist so no supplemental moisture was needed. The patient received education regarding how to use and apply the product at home (daily application after cleaning with sterile saline) and I dispensed a one-month supply of Helix 3-CP to the patient following the billing protocol above.

Due to the patient’s deformity and neuropathy, I dispensed a post-op shoe with a diabetic orthotic to the patient in order to keep the hallux from rubbing.

If the patient had not been able to apply the dressing at home or required assistance, I would have dispensed the product and then called home health to come in and provide care with the product I dispensed. As I mentioned above, if the patient were already in home health, I would not have been able to dispense the product through the office. I would have then had to write a prescription for the product for home health to order and use.

I saw the patient weekly for four weeks. The wound was completely closed by the fourth week.

In Conclusion
Despite limited studies, wound dressings containing collagen clearly provide some benefit in the treatment of diabetic foot ulcers and one should consider them among the myriad of wound dressings available to clinicians. Though there are several collagen powders on the market, there has not been sufficient evidence to prove the superiority of a particular collagen biological source or combination over another.

In choosing the best collagen powder for the clinic, one should take into account cost, the properties of the collagen, and the ease of use and availability.

As with any wound product, proper debridement, offloading and education are critical. Lastly, providing wound care products for your patients in the office can also be a tremendous convenience for your patients as well as financial benefit for your practice.

Dr. Moore has a Masters Degree in Medical Education and is in private practice in Somerset, Ky. He is a frequent writer and lecturer, and serves on the board of the American Academy of Podiatric Practice Management. Dr. Moore is a former Diabetic Foot Fellow at the University of Texas Health Science Center. Dr. Moore has disclosed that he is a lecturer and consultant for Amerx Health Care Corp.

References

1. Falanga V. Classifications for wound bed preparation and stimulation of chronic wounds. Wound Repair Regen. 2000;8(5):347-352.
2. Black E, Vibe-Petersen J, Jorgensen LN, et al. Decrease of collagen deposition in wound repair in type 1 diabetes independent of glycemic control. Arch Surg. 2003;138(1):34-40.
3. Smith KJ, Skelton HG Barrett TL, et al. Histologic and immunohistochemical features in biopsy sites in which bovine collagen matrix was used for hemostasis. J Am Acad Derm. 1996;34(3):434-438.
4. Kolenik SA, McGovern TW, Leffell DJ. Use of a lyophilized bovine collagen matrix in postoperative wound healing. Dermatol Surg. 1999;25(4):303-307.
5. Schultz G, Wysocki A. Interaction between extracellular matrix and growth factors in wound healing. Wound Repair Regen. 2009; 17(2):153-62.
6. Postlethwaite AE, Kang AH. Collagen and collagen peptide-induced chemotaxis of human blood monocytes. J Exp Med. 1976; 143(6):1299-1307.
7. Shoulders MD, Raines RT. Collagen structure and stability. Ann Rev Biochem. 2009; 78:929–958.
8. Holmes C, Wrobel JS, Maceachern MP, Boles BR. Collagen-based wound dressings for the treatment of diabetes-related foot ulcers: a systematic review. Diabetes Metab Syndr Obes. 2013; 6:17–29.