From the Guidelines
Outpatient management of diabetic foot ulcers should prioritize sharp debridement, wound cleansing, and dressing selection based on wound characteristics, along with pressure offloading and glycemic management, as the cornerstone of treatment. The most recent and highest quality study, 1, provides guidelines on interventions to enhance healing of foot ulcers in people with diabetes, emphasizing the importance of sharp debridement and basic wound dressings to absorb exudate and maintain a moist wound healing environment.
Key aspects of treatment include:
- Regular wound debridement using sharp debridement, with the frequency determined by clinical need 1
- Wound cleansing with normal saline or commercial wound cleansers, avoiding antiseptics that may damage healthy tissue
- Dressing selection based on wound characteristics, such as hydrogels for dry wounds, alginate or foam dressings for moderate exudate, and negative pressure wound therapy for complex wounds with moderate to heavy drainage
- Pressure offloading using total contact casts, removable cast walkers, or therapeutic footwear, with a non-removable knee-high offloading device as the first-choice offloading intervention for healing a neuropathic plantar forefoot or midfoot ulcer 1
- Blood glucose control optimized with a target HbA1c below 7.5%
- Regular follow-up every 1-2 weeks to assess healing progress and consider advanced therapies if wounds fail to improve after 4 weeks of standard care
It is also important to note that certain interventions, such as autolytic, biosurgical, hydrosurgical, chemical, or laser debridement, should not be used over standard of care 1, and that the use of topical antiseptic or antimicrobial dressings, honey, collagen or alginate dressings, and other agents should be avoided due to lack of evidence or potential harm 1.
Overall, a comprehensive and multimodal approach addressing the underlying pathophysiology of impaired wound healing in diabetes is essential for effective outpatient management of diabetic foot ulcers.
From the FDA Drug Label
REGRANEX is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control The effects of REGRANEX on the incidence of and time to complete healing in lower extremity diabetic neuropathic ulcers were assessed in four randomized controlled studies (Studies 1-4). In each study, REGRANEX in conjunction with good ulcer care was compared to placebo gel plus good ulcer care or good ulcer care alone.
The treatment options for outpatient management of diabetic foot ulcers include:
- Good ulcer care practices: initial sharp debridement, pressure relief, and infection control
- REGRANEX (becaplermin) gel: as an adjunct to good ulcer care practices, for lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply 2
- Non-weight-bearing regimen: to reduce pressure on the affected leg and foot
- Moist saline dressings: changed twice a day, to promote a moist environment and enhance wound healing
- Additional debridement: as necessary, to remove dead tissue and promote wound healing
It is essential to note that REGRANEX is not intended to be used in wounds that close by primary intention, and its effects on exposed joints, tendons, ligaments, and bone have not been established in humans 2.
From the Research
Treatment Options for Diabetic Foot Ulcers
The management of diabetic foot ulcers involves a multidisciplinary approach, including assessing the ulcer grade classification, surgical debridement, dressing to facilitate wound healing, off-loading, vascular assessment, and infection and glycemic control 3. The standard principles of care include:
- Pressure relief
- Debridement
- Infection management
- Revascularization when indicated 4
- Use of proper footwear
- Non-weight-bearing limb support
- Use of appropriate antibiotics
- Aggressive revascularization
- Control of serum glucose levels
- Careful monitoring of the ulcer 5
Debridement Methods
Debridement is widely regarded as an effective intervention to speed up ulcer healing, but the most effective method is unclear 6. The available evidence suggests that:
- Hydrogels are significantly more effective in healing diabetic foot ulcers compared to gauze or standard care 6
- Larval therapy resulted in a more than 50% reduction in wound area compared to hydrogel 6
- Surgical debridement showed no significant benefit over standard treatment 6
Novel Treatment Modalities
Novel treatment modalities, such as nonsurgical debridement agents, oxygen therapies, and negative pressure wound therapy, topical drugs, cellular bioproducts, human growth factors, energy-based therapies, and systematic therapies, have been available for patients with diabetic foot ulcers 3. However, it is uncertain whether they are effective in terms of promoting wound healing, with a limited number of randomized controlled trials 3, 4.
Multidisciplinary Management
Multidisciplinary management programs that focus on prevention, education, regular foot examinations, aggressive intervention, and optimal use of therapeutic footwear have demonstrated significant reductions in the incidence of lower-extremity amputations 7. Prompt and aggressive treatment of diabetic foot ulcers can often prevent exacerbation of the problem and eliminate the potential for amputation 7.