Oral session 11: Wound healing
O11.1
Clinical and Morphological characteristics with markers of reparation in chronic
diabetic foot ulcers with different duration
Elena Komelyagina, Moscow State Institution of Public Health “Endocrinological
Dispensary”, Moscow, Russia
Evgenia Kogan, First Moscow Medical University, Moscow, Russia
Michail Antsiferov, Moscow State Institution of Public Health “Endocrinological Dispensary”,
Moscow, Russia
Aim: to compare clinical and morphological characteristics and markers of reparation in
chronic diabetic foot ulcers with different duration.
Materials: 21 diabetic patients, with mean age 55.5 ± 6.5 years and known diabetes duration
as for 13.8 ± 8.0 years took part in this study. All patients had the signs of severe peripheral
neuropathy. 12 (57%) patients had non healed ulcers with duration less than 1 year, 9
patients (43%) had current diabetic foot with duration more or equal to 1 year.
Methods: Biopsies, were performed from the margin and central part of the lesion. Step
paraffin slides were stained with hematoxylin and eosin. The following morphological
characteristics were assessed: number of epithelial cells, severity of vascular hyalinosis,
percentage of necrotic, granulation and fibrous tissues. Immunohistochemistry, was done
with antibodies to cytokeratin (CKW), smooth muscle actin (SMA) and Ki67.
Results: The patients of group 1 was younger than patients of group 2 (51.75 ± 4.35 vs
60.44 ± 5.68, p= 0.001). The percentage of granulation tissue was higher in group 1, but
difference was not significant (52.27 % vs 33. 5%, p= 0.083). The amount of necrotic tissue
was the same in both groups (11.45 % vs 12.5%, p= 0.92).There was no difference in
severity of vascular hyalinosis between groups (p=0.9). In group 2 the content of fibrous
tissue was higher with the tendency to be significant (35.45% vs 54%, p= 0.057). Only the
number of epithelial cells were significantly higher in group 1 (0.55 vs 0.1, p= 0.031). There
was no difference in CK and SMA between groups (2.0 vs 0.8, p=0.15 and 3.8 vs 2.2, p =
0.074 respectively). Ki 67 was statistically, higher in group 1 (16.4 vs 3.5, p<0.000), which
means that this wounds have more capacity to regenerate.
Conclusion: Patients with the diabetic foot ulcers less than 1 year were characterized by
higher level of cell proliferation and epithelization, but lower level of fibrosis tissue comparing
with the patients with the diabetic foot ulcers more than 1 year. Neither vascular hyalinosis
no necrosis affect regeneration of the wound. In accordance with these findings we can
conclude that the most important factor that blocks reparation is fibrosis.
www.diabeticfoot.nl
Page 1 of 5
O11.2
Cost effective limb preservation protocol for diabetic foot patients indicated for a limb
amputation in a low income developing country
Jorge Puerta, Caja de Seguro Social, Panama, Panama
Aim: This study describes a cost effective limb preservation protocol for diabetic foot
patients indicated for limb amputation in a low income developing country. The protocol uses
Multidex® (DeRoyal, Powell, TN) as a primary dressing and gauze as a secondary dressing
to heal wounds following transmetatarsal amputation.
Method: This observational case series describes the wound care for 11 patients following
transmetatarsal amputation to preserve the limb. Wounds were dressed daily with Multidex,
a maltodextrin based dressing, as the primary dressing and cotton gauze as a secondary
dressing. Appropriate offloading was prescribed to each patient and dressing changes
occurred daily. Patients were followed up once a week for wound assessment and sharp
debridement as needed., Treatment continued until the wound resolved or the clinician
resolved the wound with grafting. Wounds were assessed by digital planimetry (Pictzar,
Elmwood NJ) to quantify wound healing through wound size reduction and granulation tissue
formation. Wound metrics were analysed by calculation of K-M survival curves.
Results / Discussion:, Ten of 11 wounds achieved complete healing during the study
without skin grafting; however the remaining wound achieved 70% healing before skin
grafting. Survival analysis indicated the median time to 85% granulation coverage was 27
day and median heal time was 103 days (Figure 1).These results are comparable to
previous studies that characterized other advanced woundcare methods1 2.
Conclusion: The results of this study demonstrate that this protocol utilizing a maltodextrin
based dressing evokes rapid wound healing in stage III and IV diabetic foot ulcers.
1 – Armstrong et al. The Lancet 366.9498 (2005): 1704 – 1710
2 – Robson et al. J of Adv Nurs. 65.3 (2009): 565-575
www.diabeticfoot.nl
Page 2 of 5
O11.3
Prospective randomized trial comparing 0.9% saline vs. 0.1% polyhexanide + betaine
instillation therapy with NPWT
Christopher Attinger, Medstar Georgetown University Hospital, Washington, United States
Negative Pressure Wound Therapy with Instillation is an adjunctive treatment that utilizes
periodic instillation of a solution and negative pressure for a wide range of wounds., A variety
of solutions have been reported with topical antiseptics as the most frequently chosen
option, while others have advocated for the use of normal saline despite its lack of antiseptic
properties., The objective of this study is to compare the clinical outcomes of 0.9% normal
saline versus 0.1% polihexanide + betaine (antiseptic)., This is a prospective, randomized,
comparative efficacy study of 100 subjects with infected wounds that required hospital
admission and operative debridement., Subjects were followed during admission and at 30
days post discharge., One hundred twenty three patients were originally approached for
participation with 100 subjects randomized., Forty-nine subjects were assigned to the normal
saline group and 51 subjects were assigned to the antiseptic group, with all subjects
included in the intention-to-treat analysis., Seventeen subjects were excluded, 7 in the
normal saline, 10 in the antiseptic group, for the per protocol analysis., The results of the
intention-to-treat and per protocol analysis were not different in the 2 groups except for the
proportion of males to females (ITT, Males %, Normal Saline= 57.14%, Antiseptic= 84.31%,
p=0.004)., There were also no differences in comorbidities, wound location, or wound
etiology., There was no difference in the outcomes of number of operations, length of
hospital stay, the proportion of closed/covered wounds during admission, and the proportion
of wounds that remained closed/covered at the 30 day follow-up post discharge., There was
a statistically significant difference in time to final surgical procedure (ITT, Normal Saline
5.73±3.75, Antiseptic 7.73±5.49, p=0.038; PP, Normal Saline 5.57±3.61, Antiseptic
7.46±4.42, p<0.035).
Our results suggest that 0.9% normal saline is as effective as 0.1% polihexanide + 0.1%
betaine for Negative Pressure Wound Therapy with Instillation.
ClinicalTrials.gov Identifier: NCT01939145
ClinicalTrials.gov URL:
https//clinicaltrials.gov/ct2/show/NCT01939145?term=normal+saline+prontosan&rank=1
www.diabeticfoot.nl
Page 3 of 5
O11.4
ProNOx 1: Improved healing and outcomes for diabetic foot wounds with a nitric
oxide generating (NOx) dressing.
Joanne Stewart, Queen Mary University London, London, United Kingdom
Joanne McCardle, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
Matthew Young, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
Michael Edmonds, King's College Hospital, London, United Kingdom
Brian Kennon, Southern General Hospital, Glasgow, United Kingdom
Atholl Johnston, Queen Mary University London, London, United Kingdom
Lynsey Beall, NHS Tayside, Dundee, United Kingdom
Graham Leese, NHS Tayside, Dundee, United Kingdom
Introduction: A randomised clinical study of a nitric oxide generating (NOx) dressing is
being conducted in six specialist diabetic foot centres. The aim is to compare healing of
diabetic foot ulcers (DFUs) with the NOx dressing against standard of care. The dressing
comprises a non-adherent mesh layer and a proprietary hydrogel layer, which, on contact,
release exogenous NOx into the wound bed. This functions to stimulate local vasodilation
and angiogenesis and as a potent antimicrobial agent, and thus, uniquely, to combat the
combination of infection and ischaemia associated with poor healing in DFUs [1].
Methods: 120 patients are included: 60 treated with NOx dressing (NOx) and 60 standard of
care (SOC). All patients with diabetes (male or female, age over 18) are eligible, having foot
ulcers >25mm2, duration over 14 days, not penetrating to tendon, periosteum or bone,
including patients with moderate ischaemia. Treatment is for 12 weeks, with 48-hourly
dressing changes, and follow-up at 3 months. The ulcer area is recorded photographically
and analysed by digital planimetry at each visit.
Results: Evaluable patients (completed 12 weeks treatment; 12 SOC: 14 NOx) are
presented (mean age, 59: 58 years; mean ulcer duration 5.6: 7.2 months). Table 1 indicates
comparative healing rates. Recorded serious adverse events include 4 SOC patients with
long-term hospitalization due to infection, 2 below knee amputations and one pacemaker
removal; one NOx patient, unrelated to dressing.
Conclusions: We present compelling early evidence of rapid healing in DFUs, by the NOx
dressing. We additionally demonstrate a significant reduction in extremely costly
complications of DFU.
1. Edmonds M. J Cardiovasc Surg.2014 Apr;55(2 Suppl 1):255-63.
Funding source:, EdixoMed Ltd., UK.
SOC
greater than original size
75-100% of original size
50-75% of original size
25-50% of original size
0-25% of original size
0-10% of original size
totally healed
n
4
1
2
1
4
2
1
NOx
%
33.3
8.3
16.6
8.3
33.3
16.6
8.3
n
1
3
2
0
8
7
5
%
7.1
21.4
14.3
0
57.1
1
50
35.7
Table 1: Wound area
www.diabeticfoot.nl
Page 4 of 5
O11.5
Outcomes of split-thickness skin graft in the management of ischemic diabetic foot
ulcers
Elias Khalil, King's College Hospital, London, United Kingdom
Hani Slim, King's College Hospital, London, United Kingdom
Hiren Mistry, King's College Hospital, London, United Kingdom
Prash Vas, King's College Hospital, London, United Kingdom
Michael Edmonds, King's College Hospital, London, United Kingdom
Raghvinder Gambhir, King's College Hospital, London, United Kingdom
Domenico Valenti, King's College Hospital, London, United Kingdom
Hisham Rashid, King's College Hospital, London, United Kingdom
Introduction and aim: Diabetic patients with critical leg ischemia (CLI) develop foot ulcers
in 15% of cases and this precedes 84% of all lower leg amputations. Following
revascularization, such large ulcers could be managed with free or pedical flaps. However,
flap complications may cause greater morbidity to patients. The aim of this study is to assess
the outcomes of split-thickness skin graft (SSG) in diabetic patients with CLI after
revascularization in the management of diabetic foot ulcers.
Methods: All patients undergoing SSG following revascularization were included. Patients’
demography, vascular intervention, SSG success and healing times were assesed. The site
of the SSG and the corresponding angiosomes (supplied by anterior tibial artery (ATA),
posterior tibial artery (PTA), or peroneal artery (PeA)) were also analyzed.
Results: In a 3-year period, 91 consecutive patients (67 men, median age; 67 years, range:
43-84) with diabetic foot ulcers/gangrene had undergone SSG., ,
The incidence of hypertension, renal failure and ischemic heart disease was 82%, 32% and
42% respectively. Ischemic ulcers were present in 67 cases (74%) and gangrene in 24
cases (26%). Fifty two cases underwent successful angioplasty. Another 39 patients
underwent infra-inguinal bypass. The corresponding angiosomes were: 44 PTA, 7 ATA, 4
PeA, 21 PTA/ATA and 15 PTA/PeA.
Nine out of the 91 SSG failed. Five ulcers did not heal, 2 SSG failed due to infection, 1 due
to severe edema and 1 due to an underlying hematoma. Sixty four percent of the ulcers
healed within 3 months. At 1-year, 90% of the SSG had completely healed.
Limb salvage at 1-year was 99% (1 patient had a major amputation within 1 year),
amputation-free survival was 90 % (8 deaths within 1 year) and there was no 30-day
mortality.
Conclusion: Ischemic foot ulcers following revascularization in diabetic patients can be
managed effectively with a SSG irrespective of the anatomical location. SSG in the
treatment of ischemic diabetic foot ulcers reduces healing time.
www.diabeticfoot.nl
Page 5 of 5