Expert Recommendations for Optimizing Outcomes ... - Wounds

1.4 Estimating the Likelihood of DFU Healing
Review of Evidence
The likelihood of complete DFU healing is determined
by multiple factors, both patient-related and wound-related.
Important patient-related factors include vascular status,
nutritional status, neurologic status, presence and severity of
soft tissue infection, osteomyelitis, Charcot, and other factors,
including glycemic control. Wound-related factors that have
been demonstrated in prospective studies to have predictive
value include the size, duration, depth, and grade of the
DFU. Larger lesions (>2 cm 2 ), chronic lesions (>6 months
- 12 months), deeper lesions, and higher grade lesions are
associated with reduced likelihood of complete healing despite
continued conventional therapy.
Margolis et al 18 pooled data from the standard care arms
of 5 clinical trials to determine the effect of wound size and
duration on the probability of healing (Figure 5). Healing rates
were lower in patients with larger wounds and longer duration
wounds. For example, wounds 12 months, which had
only a 26% probability of healing (n = 252 patients).
Group Discussion
Many DFUs heal slowly and many will not heal with
standard treatment. Healthcare providers should be keenly
aware of the serious challenges involved in treating any
DFU successfully. Patients and families must be educated
about the poor prognosis for healing in general and the
critical importance of strict compliance in order to maximize
the probability of success. The studies above clearly
show that even in patients with DFUs that are small and
of shorter duration, many lesions will not heal with conventional
therapy, eg, in the Margolis trial described above,
even among patients with small DFUs that were present
for less than 6 months more than half (57%) did not heal at
20 weeks. Of course, in larger wounds of greater duration
the likelihood of healing is even lower. Therefore, from the
first day of treatment onwards, all patients need to understand
that DFUs are very difficult to heal with conventional
therapy and that most patients will ultimately need
to receive evidence-based advanced therapy to maximize
their odds of achieving complete healing.
In addition, the group believed that in many cases the
likelihood of successful healing is overestimated by both
clinicians and patients and that greater awareness of the
challenges DFUs present may lead to better clinical decisions
and higher compliance.
Suggested Readings
• Margolis DJ, Kantor J, Santanna J, Strom BL, Berlin JA. Risk
factors for delayed healing of neuropathic diabetic foot ulcers:
a pooled analysis. Arch Dermatol. 2000;136:1531-1535. n
100%
% Healed Within 20 Weeks
75%
50%
25%
% Healed
0 %
4 12 12
()*+,#-./0# ()*+,#1*234)+# ()*+,#-./0#3+,#
Wound Size 1*234)+#
& Duration
Wound Size
cm 2
Wound Duration
months
cm 2 & months
Sample Size: 347 123 116 202 88 189 120 252
Figure 5. Cumulative healing rates within 20 weeks of care of DFUs.
Adapted from Margolis DJ, et al. Risk factors for delayed healing of neuropathic diabetic foot ulcers: a pooled analysis. Arch Dermatol. 2000;136:1531-1535.
10 Expert Recommendations for Optimizing Outcomes Utilizing Apligraf ® for Diabetic Foot Ulcers