It Should Be Easier To Heal Diabetic Foot Ulcers!

Why Is It So Difficult?

One reason is that OFFLOADING, which is necessary to heal plantar DFUs, is grossly underutilized. Fewer than 10% of patients receive any type of proven-effective offloading care.

Provided there is adequate blood circulation, most plantar diabetic foot ulcers (DFUs) can be healed with proper offloading and regular debridement. For most cases, expensive adjunct therapies such as tissue grafts and advanced dressings are unnecessary, or are of only of secondary importance for healing DFUs.

And yet, recent data shows that the number of diabetes related amputations is actually increasing, including major amputations. Additionally, multiple studies over the past 20 years have shown that most plantar DFU patients do not receive any type of plantar offloading. So, with all of the expensive and advanced wound care technologies that are available to practitioners, why are amputations increasing?

Certainly, healing rates would improve immediately with greater use of effective offloading devices.

Patients And Doctors Need New Choices

For nearly 50 years the Total Contact Cast (or TCC) has been described in the literature as the “gold standard” for offloading DFUs. Consequently, TCC is also the only reimbursed offloading method. 

And yet, TCC is used for under 5% of DFU patients.  Why is this? Because patients dont want to be put in TCCs, and health care practitioners dont want to apply TCCs. 

• For patients, TCCs can represent a barrier to working, driving, walking, bathing; and cause them to become a burden to their family or lose their independence. Additionally, the frequent cast changes that are typically required with TCC s can strain family budgets, interfere with work schedules, and create logistical problems.

• For healthcare practitioners, TCCs are associated with contraindications and secondary complications, resistance from patients, are technique dependent, as well as can be time consuming and require multiple staff members to apply, and are inadequately reimbursed. Additionally, the requirement to change casts frequently can create scheduling issues for medical offices and expose patients to increased risk of infection should scheduled cast changes not occur.

Is there another option? YES! The FORS-15 Insole is a simple and proven-effective offloading option than can make an immediate impact for many patients.

Proven Effective:

A recent study at Temple University demonstrated that FORS reduced pressure on ulcerated areas an average of 43.4%, without creating any unwanted increases in pressure along the edges of the ulcerated areas.

Patients Can Maintain Their Mobility

The FORS -15 insole in a standard surgical shoe can be tolerated by most patients without substantially altering their gait (how they must move to walk).

Offloading devices that force patients to alter their gate to ambulate, such as the TCC, CAM boots (Controlled Ankle Motion), and forefoot or rearfoot “wedge” shoes can often increase the risk of falling and cause secondary injuries such as abrasions, broken bones or worse. For patients already at risk of falling due to diabetic neuropathy and/or other conditions, devices that further increase their risk of falling may be contraindicated or simply unacceptable.

Even if not recommended, many patients must be able to drive to receive DFU care.

Many patients do not have family members to drive them to their medical appointments, and / or may need to drive to maintain their employment to be able to pay for their medical care. For DFUs that affect the right foot (used for driving), TCCs or other “non-removable” offloading devices that prevent patients from driving may also prevent them from being able to receive care. For many DFU patients and their families, loss of mobility can cascade into loss of employment income and increased transportation requirements that create unsustainable stress. While driving with a DFU is not ideal, for many patients its a necessity to access care. With the FORS-15, patients can strategize with their healthcare providers to determine how to best maintain effective DFU offloading while meeting their mobility needs.

Durability and Cleanliness:

The FORS -15 insole is constructed from durable materials that provide effective offloading for significantly longer than is required to heal most ulcers. The FORS-15 insole is easily cleaned and disinfected by soaking in diluted chlorine bleach for 5 minutes, then rinse and air dry. (Dilute 1 part standard bleach with 19 parts tap water).

Easy for Patients and Practitioners:

The FORS insole with a standard surgical shoe is priced below $90. For a small investment, patients can receive effective offloading for their DFU with the convenience of wearing a simple and removable surgical shoe. FORS can be worn by most patients without creating any significant increase in their risk of falling. The FORS is a convenient and effective alternative to TCCs, and can help many patients improve the likelihood of healing their diabetic foot ulcers.

For physicians, FORS is a viable solution for their patients, that does not put a strain on the practice. Wholesale pricing is available to enable physicians to dispense a proven and wearable offloading shoe, and charge a reasonable fee for their services.

Physician Feedback

• "The FORS insole is easily modified to address patients, and is also very effective....It is made of rugged materials that will hold up and maintain offloading for a year...and it doesn't produce an 'edge effect'...It is a great insole, it just works...I really think it is the best of all the offloading insoles."

• "The FORS innersoles cost a bit more up front, but they offload better, so wounds close faster, meaning fewer overall visits and a lower complication rate, saving patients money in the long run. The FORS holds up as long or longer than 3 cheap innersoles, which are prone to flatten and break apart, putting more pressure back on the wound...The competition isn't even close."

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Some Resources That are Worth Checking Out

1. "Comparison of two pixelated insoles using in-shoe pressure sensors to determine percent offloading: case studies"; Multiple article series, Journal of Wound Care / Wound Central, May 2021
2. "Who Should Pay For Offloading Footwear To Treat DFUs?", M. Goldberg, Todays Wound Clinic, Jan 2018
3. "Charcot  Versus Osteomyelitis""(FORS Used For Charcot), H. Penny et al, APWH poster, Oct 2019,
4. "FORS-15 Clinical Evaluation - Multicenter" poster presentation, H. Penny, J. McGuire et al, A-DFS, Nov 2017,
5. "FORS-15 Clinical Evaluation, Montefiore Mt. Vernon Hospital", P. Rafat et al, SAWC poster, Nov 2016
6. "The DFU Dilemma: Is the Total Contact Cast a True “Gold Standard?", H. Penny, Lower Extremity Review (LER), September 2018,
7. "Expert Opinion, Advances and alternatives in diabetic ulcer offloading", Lower Extremity Review, J McGuire et al, August 2018
8. "Reexamining The Gold Standard For Offloading Of DFUs"; J. McGuire et al, Podiatry Today, March 2017
9. "DFU offloading: we know what works, why don’t we do it?", H. Penny; Journal of Wound Care, North American Supplement, Vol 28, #5, May 2019
10. A Guide To Offloading The Diabetic Foot, N. Martin et al, Podiatry Today (Continuing Education), Vol 18, #9, September 2005
11. Use of Pressure Offloading Devices in Diabetic Foot Ulcers, Wu et al, Diabetes Care, VOL31, #11, Nov 2008
12. Why is it so hard to do the right thing in wound care?, Fife C. et al, Wound Rep Reg (2010) 18 154–158