Total contact casting for diabetic foot ulcers

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Title: Total contact casting for neuropathic foot ulcers
and Acute Charcot’s arthropathy in diabetes – evidence
based care pathway
Author: Dr V Baskar, on behalf of the Wolverhampton Diabetes Foot Group
Date: Jan 2013
Version: Draft pending agreement with Orthopedic and Vascular teams
Review date: Jan 2015
Approval needed from: Diabetes LIT
Dissemination: Diabetes foot group
Archived: Wolverhampton Diabetes Centre Website as part of Foot guidance
TCC’s for Diabetic Foot Ulcers – Care pathway
Page 1 of 9
Summary

Continued mechanical trauma is a key factor responsible for the failure of healing
of chronic neuropathic foot ulcers

Pressure offloading reliably reduces plantar pressure and has been shown to
increase healing rates and shorten healing times

Total Contact Casts are believed to be the gold standard method with better and
faster healing rates compared to other removable off-loading devices - 89-95%
ulcers healed at 12 weeks with 20-25d reduction in healing times
o TCC’s superiority is related to poor compliance with removable devices

The majority of studies excluded ulcers that were clinically infected or those
patients with significant peripheral vascular disease

Where TCC’s are used in closely monitored settings, iatrogenic contact
ulcerations are seen in very small proportion of patients - reversible minor
complication in 1 in 20 casts and permanent sequel from casts in 1 in 400

TCC’s results in considerable reduction in the size of the limb and need
mandatory removal and reapplication at the end of the first week
o For the management of underlying ulcer and monitoring for iatrogenic
ulcers, TCC’s will also need reapplying at 2-3weekly intervals thereafter

The time and resource constraints from repeated reapplications of TCC’s is
hugely outweighed by costs and morbidity of managing a non-healing ulcer

Limited studies have successfully used TCC’s with ulcer windows to circumvent
logistical difficulties without concern of ulcer herniation through such windows

Recent studies have also attempted to make Removable offloading devices
‘instantly irremovable’ using single layer of fiberglass cast and have shown
equivalent healing to TCC’s and at lower costs although these findings need
replication in larger studies

TCC’s are also the gold standard treatment for Acute Charcot’s foot
o Casting is however needed for longer periods and will also need
mandatory removal and reapplication at weekly intervals
TCC’s for Diabetic Foot Ulcers – Care pathway
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TCC in Diabetic neuropathic plantar ulcers and Acute Charcot
Non healing (>3months) neuropathic plantar ulcers despite
optimal footwear or Acute Charcot arthropathy
Clinically significant Infection or Peripheral vascular disease*
(* Absent both pulses in ulcerated feet or Claudication <200yds or ABPI<0.7
or Evidence of ischemia)
YES
Eradicate infection
Consider vascular assessment/referral
No infection
&
No PVD
Consider offloading with casts
Compliance to offloading device likely
Removable cast walkers (RCW)
Compliance to offloading device doubtful
Total Contact Casts (TCC)
Liaise with plaster room
Instant TCC
(Fiberglass cast over RCW)
TCC with ulcer window
Conventional TCC
Selected cases where
ulcer can be made nonweight bearing
End of 1st week & at
least &
2 weekly
thereafter
Removal
Reapplication
Mandatorily at end of 1st week
At least 2-3weekly thereafter (weekly if Acute Charcot)
Ongoing f/up
In WDC
At least 2 weekly until ulcer healed
Poor response at 12 weeks
(longer for Acute Charcot)
Consider alternative options
TCC’s for Diabetic Foot Ulcers – Care pathway
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Governance issues

The application of Total Contact Casts must be a Consultant level decision

The management plan on the choice of cast method, duration of treatment and
monitoring frequency have to be documented in the notes/Letters drive and
copied to the Plaster team

In selected cases where ulcers can be safely made non-weight bearing, casts with
ulcer windows can be considered but with clear documentation as above

All requests for TCC’s for patients with diabetes must involve the Specialist
Chiropody service in the Diabetes Centre and such details prospectively
maintained in a Cast register to allow secure audit trail

Any iatrogenic complications while on contact casts has to be reported as a
clinical incident and such incidents to be maintained in the Risk Register in WDC
and to be shared in the Foot group meeting periodically

Patient information leaflets are to be issued following application of TCC’s
TCC’s for Diabetic Foot Ulcers – Care pathway
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Total contact casting for diabetic foot ulcers – evidence
based care pathway
One of the key factors responsible for the failure of chronic ulcers to heal is continued
mechanical trauma to the bed of the healing wound, often occurring during normal
activities of daily living and encouraged by the insensate foot. The regenerating wound
bed can be protected by a variety of pressure offloading methods including casting,
bracing, footwear and surgical offloading.
1. Do Contact casts work?
Pressure relief: Contact casts have been shown to reduce plantar pressure by 32-69%
(1). This study was however done in healthy non-deformed and non-ulcerated feet in
individuals without diabetes. In another study involving 25 patients with diabetes and
foot ulcers, removable and non-removable casts were found to reduce pressure in the
forefoot to a similar extent (2).
Efficacy: As with many other areas of diabetic foot, the quality of available research in
this topic is poor and high quality multi-centre RCT showing efficacy of contact casting
is lacking. There have however been a few single centre RCT’s involving small patient
samples that have shown higher and quicker healing rates of plantar ulcers with total
contact casts (TCC) compared to other modalities of offloading (3-6). The proportion of
ulcers healed at 12weeks was 89-95%, 52-79% and 30-50% with TCC, Removable Cast
Walkers (RCW) and therapeutic shoes respectively. Median time to healing of ulcers was
also significantly less with TCC (33-41 days with TCC, 50-58d with RCW and 6165days with therapeutic shoes). The location of the ulcer and presence of deformity has
impact on the effectiveness of TCC with forefoot ulcers healing significantly faster than
non-forefoot ulcers (10) and midfoot deformities (commonly observed in Charcot) having
the longest healing times (11-12). In general, the inferior results of removable offloading
devices are believed to be related to poor compliance to non-weight bearing. Ulcer
patients have been shown to take an average of 72% of their daily steps unprotected when
TCC’s for Diabetic Foot Ulcers – Care pathway
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given a removable device to offload (7). Attempts to render removable cast walkers
instantly non-removable using easier techniques (e.g. single layer of fiberglass cast over
RCW) have been shown to have similar results to conventional total contact casts at
much lower time and costs involved (8-9).
Histological studies: A small study comparing histology of diabetic foot ulcers in
patients with and without total contact casts found a significantly more reparative
histological pattern (with neo-capillaries and fibroblasts) in the TCC group compared to
the inflammatory pattern observed in the conventional non-TCC group (13). This lends
further proof at cellular level that pressure relief leads to a favourable healing
environment.
2. What are the risks associated with TCC?
Time and resource constraints: The application and repeated replacements of casting
devices has been an expensive and time-consuming task with additional impact from
need for optimal training to the technicians. The cost of managing non-healing diabetic
foot ulcers (£300 per month) and its most feared consequence of limb loss (£10000 prior
to any rehabilitation cost), however, is considerable, and most studies have concluded the
cost effectiveness of total contact casts done in the optimal setting, especially where
instant TCC methods are chosen (4, 9, 14).
Iatrogenic ulcerations: Ulcerations occurring while within the cast due to pressure or
friction from cast material is a risk that can be minimized with careful casting techniques.
In a large retrospective review of 398 casts in 70 individuals (92% with diabetes), one
minor complication was observed in every twenty TCC’s and 30% of patients suffered
one complication during the course of their treatment (15). All new ulcers except one
healed with simple modalities within 3 weeks and one patient ended up requiring toe
amputation (permanent sequelae from cast of 1 in 400).
Ulcer recurrence post casting: One study estimated a 20% reulceration rate following
TCC largely related to lack of compliance to treatment program although little mention
TCC’s for Diabetic Foot Ulcers – Care pathway
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was made on specialist footwear use post healing of ulcerations (16). Several studies have
confirmed the preventative value of specialist footwear for reulcerations (17-18).
Monitoring issues: There is genuine concern that non-removable casting of the foot
would render it inaccessible for monitoring for new ulcers and of progress of existing
ulcers. In addition, there is considerable reduction in the swelling and the size of foot
following plaster casts that would make them too big and at risk of friction and contact
ulcers especially after the first week of their application. Good practice would suggest the
mandatory need for removal and reapplication of casts after the first week with
subsequent reapplications guided by clinical progress but at the very least at 2-3 weekly
intervals. Where contact casts have been done in centers with such robust onward
monitoring, the incidence of iatrogenic problems from TCC has been incredibly low (15).
Casts with ulcer windows: Others have studied TCC’s with windows over ulcers that
can be safely made non-weight bearing, as alternatives, and found comparable healing
rates to non-removable TCC (19). This comes with the additional logistical advantages of
not having to remove and reapply casts many times and allows on-going monitoring of
the wound. While there is a theoretical risk of ulcer herniation through the window,
where such patients are closely monitored, this risk is believed to be very small. Instant
TCC’s, however, has the potential to be the most effective and the safest way of
offloading needing very little additional training.
3. Challenging limbs
Most studies of TCC have excluded patients with significant infection, osteomyelitis or
peripheral vascular disease (especially where ABPI is <0.5). One study placed 98
subjects with vascular insufficiency and/or mildly infected limbs in TCC and showed
encouraging results with successful outcomes in all situations except neuroischemic heel
ulcers with infection although the best outcomes were for those subjects without vascular
disease or infection (20). In another study involving immunosuppressed post transplant
patients with diabetes, TCC was found to be as safe and efficacious but with longer
healing times compared to immunocompetent comparators (21). Until these findings are
TCC’s for Diabetic Foot Ulcers – Care pathway
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replicated in other good quality studies, TCC should remain contraindicated in patients
with significant peripheral vascular disease.
4. Acute Charcot foot and TCC
Immobilization is the cornerstone treatment for Acute Charcot and TCC’s are again
believed to be the gold standard treatment for patients with this condition. The general
principles and efficacy of TCC in Charcot is similar to what is described for neuropathic
ulcers. In addition, given the higher possibility of progression and ulceration in Acute
Charcot, these patients will need mandatory removal and reapplication of TCC’s at
weekly intervals. The length of time the limb needs to be casted can vary from few weeks
to several months and is best judged by clinical, radiological and dermal thermometric
signs. Also, ulcers following Charcot commonly need longer times in casts to heal (11,
12).
Conclusion
Despite the lack of large multi-centered RCT’s to strengthen the role of TCC, currently
available studies do support their efficacy and safety in treatment of diabetic foot ulcers.
However, despite the well-documented gold standard status of TCC for the healing of
diabetic foot ulcers, a recent survey found less than 2% of specialists surveyed to be this
modality for the majority of their patients with DFU (22). The logistics and the perceived
costs may have been important factors in its under use although the instant TCC concept
offers genuine hope. The instant TCC technique can be achieved with a lot less training
and will allow the treatment modality to be used far more widespread than traditional
TCC and at much lower costs and time although its results need replicating in other
centers.
TCC’s for Diabetic Foot Ulcers – Care pathway
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References
1. Wertsch et al, J rehab res devpt 1995; 32: 205-9
2. Lavery et al, Diabetes Care 1996; 19: 818-21
3. Mueller et al, Diabetes Care 1989; 12: 384-388
4. Armstrong et al, Diabetes Care 2001; 24: 1019-22
5. Armstrong et al, Diabetes Care 2005; 28: 551-54
6. Caravaggi et al, Diabetes Care 2007: 30: 2577-78
7. Armstrong et al, Diabetes Care 2003; 26: 2595 –97
8. Piaggesi et al, Diabetes Care 2007; 30: 586-90
9. Katz et al, Diabetes Care 2005; 28: 555-59
10. Walker et al, Arch Physical Medical Rehabilitation 1987; 68: 217-21
11. Edmonds M, Drugs 2006; 66: 913-29
12. Sinacore et al, Foot and Ankle Intl 1998; 19: 613-18
13. Piaggesi et al, Diabetes Care 2003; 26: 3123-28
14. Shearer et al, The Diabetic Foot 2003; 6: 30-37
15. Guyton et al, Foot and Ankle Intl 2005; 26: 903-7
16. Helm et al, Archives Physical Medical rehab 1991; 72: 967-70
17. Uccilli et al, Diabetes Care 1995; 18: 1376-78
18. Busch et al, Diabetic Medicine 2003; 20: 665-69
19. Ha Van et al, Diabetes Care 2003; 26: 2848-52
20. Nabuurs-Franssen et al, Diabetes Care 2005; 28: 243-247
21. Sinacore DR. Archive Physical Medicine Rehab 1999; 80: 935-40
22. Wu et al, Diabetes Care 2008; 31: 2118-19
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