Medical risk factors in diabetic patients with foot ulcers and severe peripheral vascular disease and their influence on outcome

doi:10.1016/1056-8727(92)90032-G

Journal of Diabetes and its Complications

Volume 6, Issue 3, July–September 1992, Pages 167-174

https://doi.org/10.1016/1056-8727(92)90032-G Get rights and content

Abstract

The association between medical risk factors and the outcome of foot ulcers was evaluated in 208 consecutive diabetic patients with severe peripheral vascular disease (systolic toe blood pressure ≤45 mm Hg). All patients were treated and followed by the same foot care team. Eighty patients healed primarily, 83 healed after a minor or major amputation, and 45 died. The systolic toe blood pressure was higher among primary healed (30 ± 13 mm Hg) compared with amputated (22 ± 15 mm Hg; p < 0.001) and deceased patients (20 ± 14 mm Hg; p < 0.001). The patients were comparable regarding age, sex, and diabetes and wound duration. Only 41 (19%) patients had intermitten claudication, whereas 153 (77%) lacked palpable pedal pulses, 36% of whom healed primarily. Rest pain occurred in 72 (33%) patients, 38 (47%) of whom had an amputation and 18 (25%) who healed primarily (p < 0.01). Peripheral edema and proteinuria were more common among patients who healed after amputation compared with those who healed primarily (p < 0.001 and p < 0.01, respectively). Signs of sensory neuropathy were found in 158 (77%) patients. There were no differences concerning cardiovascular disease, smoking habits, or short-term metabolic control between patients who healed primarily or after an amputation.

In conclusion, diabetic patients with foot ulcers and severe peripheral vascular disease with low systolic toe blood pressure were not excluded from the possibility of primary healing. The most important risk factors for amputation were a systolic toe pressure of less than 30 mm Hg, peripheral edema, rest pain, and proteinuria.

References (33)

ME Edmonds
The diabetic foot: Pathophysiology and treatment
M Gutman et al.
Gangrene of the lower limbs in diabetic patients: A malignant complication
Am J Surg
(1987)
I Faris et al.
Skin perfusion pressure in the prediction of healing in diabetic patients with ulcers or gangrene of the foot
J Vascular Surg
(1985)
J Apelqvist et al.
The influence of external precipitating factors and peripheral neuropathy on the development and outcome of diabetic foot ulcers
J Diabet Complications
(1990)
U Rosenqvist
An epidemiological survey of diabetic foot problems in the Stockholm County 1982
Acta Med Scand Suppl
(1984)
TW Klamer et al.
The influence of sepsis and ischemia on the natural history of the diabetic foot
Am Surg
(1987)
DE Bild et al.
Lower-extremity amputation in people with diabetes. Epidemiology and prevention
Diabetes Care
(1989)
J Apelqvist et al.
Prognostic value of systolic ankle and toe blood pressure levels in outcome of diabetic foot ulcer
Diabetes Care
(1989)
P Holstein et al.
Healing of ulcers on the feet correlated with distal blood pressure measurements in occlusive arterial disease
Acta Orthop Scand
(1980)

DE Ramsey et al.

Toe blood pressure a valuable adjunct to ankle pressure measurement for assessing peripheral arterial disease

J Cardiovasc Surg

(1985)

SA Carter

The relationship of distal systolic pressures to healing of skin lesions in limbs with arterial occlusive disease with special reference to diabetes mellitus

Scand J Clin Lab Invest Suppl

(1973)

GE Bone et al.

Toe blood pressure by photoplethysmography: An index of healing in forefoot amputation

Surgery

(1981)

J Apelqvist et al.

Wound classification is more important that site of ulceration in the outcome of diabetic foot ulcers

Diabetic Med

(1989)

J Apelqvist et al.

The importance of peripheral pulses, peripheral oedema and local pain for the outcome of diabetic foot ulcers

Diabetic Med

(1990)

FW Wagner

The dysyascular foot: A system for diagnosis and treatment

Foot Ankle

(1981)

Cited by (59)

Toe Pressure in Predicting Diabetic Foot Ulcer Healing: A Systematic Review and Meta-analysis
2019, Annals of Vascular Surgery
Foot ulceration is the most frequently recognized lower extremity complication in diabetic patients. Predicting wound healing is an essential step in the management of diabetic foot ulcers (DFUs), as it is estimated that early detection and appropriate treatments may prevent up to 85% of amputations. Toe systolic blood pressure (TBP) is a quick and portable bedside assessment and is less affected by medial sclerosis of arteries present in the diabetic population compared to other measurements like ankle–brachial index. This systematic review seeks to evaluate the sensitivity and specificity of toe pressure in prediction of DFU wound healing.
PubMed/MEDLINE and EMBASE databases were systematically searched up to September 20, 2017 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All randomized control, prospective and retrospective trials were considered for inclusion if they reported healing rates of DFUs with respect to different TBP readings. Healing was defined to be intact skin for at least 6 months or at time of death. Quality assessment of articles was performed using the RevMan Quality Assessment. Information on healing rates with respect to different TBP values was extracted. Summary estimates of sensitivity and specificity of TBP in predicting healing of DFU wounds were obtained using a bivariate model.
A total of 580 articles were screened. Eight studies (6 prospective and 2 retrospective) inclusive of 909 patients were eligible for inclusion. It was found that a TBP of more than 30 mm Hg is associated with a sensitivity and specificity of 0.86 and 0.58 respectively for healing of DFUs.
A TBP of more than 30 mm Hg is sensitive but not specific in the prediction of healing of DFUs. Due to its portability and quick analysis, TBP may be used as a bedside assessment to complement current clinical parameters to aid in predicting the healing of diabetic foot ulcers.
Early revascularization after admittance to a diabetic foot center affects the healing probability of ischemic foot ulcer in patients with diabetes
2014, European Journal of Vascular and Endovascular Surgery
Citation Excerpt :
Peripheral edema has previously been shown to be related to foot ulcer healing in patients with diabetes.6,24 Peripheral edema was also found to be more common in patients with diabetes and foot ulcer who required amputation or died unhealed than in those with primary healing.6,24–26 Edema is often multifactorial in origin, and its treatment should also focus on the predisposing cause.
There is limited information about whether time from recognition of decreased perfusion to revascularization affects the probability of healing in a patient with a diabetic foot ulcer. The aim of the present study was to examine whether time to revascularization after referral to a multidisciplinary foot center was related to the outcome of foot ulcers in patients with diabetes and severe peripheral arterial disease (PAD).
Patients with diabetes, a foot ulcer, and a systolic toe pressure <45 mmHg or an ankle pressure <80 mmHg were prospectively included at the foot center, and considered for revascularization according to a preset protocol. All patients underwent invasive revascularization, either percutaneous transluminal angioplasty (PTA) or reconstructive vascular surgery. All patients had continuous follow-up until healing or death irrespective of the type of revascularization.
A total of 478 patients were included (age 74 [range 66–80] years, 60% males), of whom 315 patients (66%) had PTA, and 163 (34%) had reconstructive surgery. Of the 478 patients, 217 (45%) healed primarily, 88 (19%) healed after a minor amputation, 76 (16%) healed after a major amputation and 92 patients (19%) died unhealed. The median time from inclusion in the study to revascularization was 8 weeks (3–18 weeks). Time to vascular intervention within 8 weeks (p < .001), maximum Wagner grade reached <3 (p < .001), absence of peripheral edema (p = .033), and presence of intermittent claudication (p = .001) were related to a higher probability of healing.
Time to revascularization and extent of tissue damage were related to the probability of healing of ischemic foot ulcer in patients with diabetes over time. In the presence of a decreased perfusion in a patient with diabetes and a foot ulcer not only revascularization per se but also timing of revascularization is important for the possibility of healing without a major amputation.
Assessment of risk factors in diabetic foot ulceration and their impact on the outcome of the disease
2009, Primary Care Diabetes
Citation Excerpt :
The main examined sensory modalities were pain, touch and vibration sense over the medial malleollus of the affected foot. The patient was considered to have peripheral vascular disease that may affect the development of ulcer if there was absent pulsation of either the dorsalis pedis or posterior tibial artery, or ankle–brachial systolic blood pressure index <0.80 [32]. Chronic renal insufficiency was stratified as creatinine >4.0 mg/dl, current dialysis or a history of renal transplantation [33] while the presence of diabetic retinopathy was assessed by one independent ophthalmologist.
The current study aims to identify risk factors for diabetic foot ulcer and their impact on the outcome of the disease.
Three hundred diabetic patients were enrolled in the study. One hundred eighty subjects with diabetic foot ulcer and 120 diabetic controls without foot lesions. All expected risk factors were studied in all patients and after a follow up period, patients with diabetic foot ulcer were classified into group A (patients with healed ulcers) and group B (patients with persistent ulcer or ended by amputation). The risk factors were reanalyzed in both groups to find out their impact on the outcome of the disease.
The following variables were significant factors for foot ulceration: Male gender (P = 0.009), previous foot ulcer (P = 0.003), peripheral vascular disease (P = 0.004), and peripheral neuropathy (P = 0.006). Also lack of frequent foot self-examination was independently related to foot ulcer risk. The outcome was related to longer diabetes duration (P = 0.004), poor glycaemic control (P = 0.006) and anaemia (P = 0.003) and presence of infection (P < 0.001).
Peripheral vascular disease and peripheral neuropathy together with lack of foot self-examination, poor glycaemic control and anaemia are main significant risk factors for diabetic foot ulceration.
Four-fold increase in foot ulcers in type 2 diabetic subjects without an increase in major amputations by a multidisciplinary setting
2009, Diabetes Research and Clinical Practice
Citation Excerpt :
As secondary prophylaxis, a rapid and effective contact system in the foot clinic when ulcer recurrences occur seems mandatory. Foot ulcers are an important risk factor for and preclude nearly all amputations above or under the knee [28,5,6]. Strong associations were found between amputations and other diabetic complications, such as peripheral neuropathy and peripheral ischemia, which is in concordance with previous studies [7,8].
We observed a large increase in type 2 diabetic subjects with foot ulcers in our diabetic outpatient foot clinic and wanted to identify the amputations rate and individuals at risk of amputations by comparing those who had had a regular control in the multidisciplinary foot clinic prior to the amputations and those who had not.
We examined all clinical records from the orthopaedic surgery department and the diabetic outpatient foot clinic of diabetic patients who underwent amputations for 6 years.
Eighty-eight patients with type 2 diabetes underwent 142 amputations; 42 major and 100 minor amputations. There was no increase in the number of major amputations in this period. In the group not followed in the foot clinic prior to amputations we showed a greater major amputations rate (p < 0.05), although this group had a shorter duration of diabetes and less retinopathy, nephropathy and AMI/stroke. Everyone in both groups had severe neuropathy and ischemia.
A multidisciplinary diabetic foot clinic may decrease the risk of major amputations in type 2 diabetic subjects with foot ulcers. Severe neuropathy and ischemia were the most important risk factors.
Fifty percent area reduction after 4 weeks of treatment is a reliable indicator for healing-analysis of a single-center cohort of 704 diabetic patients
2009, Journal of Diabetes and its Complications
Citation Excerpt :
In our analysis, the probability of healing was significantly decreased for ulcers that did not reach 50% area reduction after 4 weeks of treatment. It has been shown that ischemic wounds (Apelqvist, Larsson, & Agardh, 1992) have a significantly lower healing rate and a higher risk for amputation. Similarly, wound infection has an impact and is very likely to delay the healing process (Lipsky et al., 2006).
The aim of the study was to investigate whether an area reduction greater than 50% within the first 4 weeks of treatment is associated with a higher long-term probability of healing.
We treated diabetic foot ulcers according to a comprehensive interdisciplinary wound care protocol. Follow-up was documented through a special wound documentation system. Data were entered into SPSS for statistical analysis to calculate the probability of healing according to the Kaplan–Meier method. Results were expressed as median (minimum–maximum), and the percentage of area reduction (PA) was defined as [(area_{4 weeks}/area_baseline)×100)/area_baseline. Patients were divided into responders when PA reached at least 50% and nonresponders when PA was less than 50%. Healing was defined as PA=100%.
In total, 704 patients were included into the analysis. Median time of follow-up was 71 (2–365) days. Wound duration was 31 (1–4018) days, and the initial wound size was calculated to be 1.18 (0.1–99) cm². In 27.8%, there was a positive probing to bone; in 64.5%, both pedal pulses were not palpable. Major amputation rate was 2.8% and minor amputation rate was 10.2%. The overall probability of healing was 35% after 12 weeks, 41% after 16 weeks, and 73% after 1 year. The surrogate visit (4 weeks) was performed after a median of 27 (14–42) days without a difference between responders and nonresponders. There were 334 (47%) responders and 370 (53%) nonresponders. Responders had a significantly higher probability of healing compared with nonresponders (12 weeks: 52.3% vs. 18.4%, P=.0001; 16 weeks: 46.7% vs. 26.5%, P=.0001; 1 year: 82.5% vs. 64.9%, P=.0001).
The calculation of the percentage of area reduction after 4 weeks of treatment is a valid tool to estimate the probability of healing. In clinical practice, a reevaluation of the treatment schedule is recommended for wounds that do not reach 50% area reduction within the first 4 weeks of therapy.
Factors associated with treatment failure in patients with diabetic foot infections: An analysis of data from randomized controlled trials
2008, Diabetes Research and Clinical Practice
Citation Excerpt :
The production of biofilms, in which antibiotic penetration may be prohibited, may also contribute to treatment failures. Although several studies were performed to identify factors that could be associated with the development of diabetic foot ulcers or infections [39–44], we are aware of only one study that sought to identify factors that could be associated with adverse outcome. The authors of this study concluded that fever, increased serum creatinine levels at baseline, prior hospitalization for diabetic foot lesions and gangrenous lesions were the independent factors associated with treatment failure [45].
Although several antibiotics have been studied for the treatment of foot infections, their effectiveness has been considered to be similar. The scope of this analysis was the identification of factors that are associated with treatment failure based on evidence from randomized controlled trials (RCTs).
Two reviewers independently extracted data from published RCTs comparing different antibiotics for diabetic foot infections (DFIs).
The combined observed treatment failure was 22.7% in the 18 RCTs included in the analysis. When different regimens of various antibiotics (penicillins, carbapenems, cephalosporins, and fluoroquinolones) were directly compared in the individual RCTs, they were associated with similar frequency of treatment failure. However, when all patients were combined, carbapenems were associated with fewer treatment failures. Also, treatment failure in patients with DFIs from whom methicillin-resistant S. aureus (MRSA) alone or as part of a polymicrobial infection was isolated was more common than in patients from whom other bacteria were isolated [24/68 (35.3%) versus 350/1522 (23%), p = 0.02]. Among patients with DFIs due to MRSA the use of linezolid was not associated with better effectiveness in comparison to other antibiotics [treatment failure: 6/19 (31.6%) versus 18/49 (36.7%), p = 0.69]. Of interest, treatment failure was similar in patients with and without osteomyelitis [44/169 (26.5%) versus 330/1424 (23.2%), p = 0.34].
The isolation of MRSA seems to be a significant factor associated with treatment failure in patients with DFIs. Further research efforts are needed for the identification of additional risk factors for treatment failure and optimization of the management of patients with DFIs.

View all citing articles on Scopus

View full text

Original articleMedical risk factors in diabetic patients with foot ulcers and severe peripheral vascular disease and their influence on outcome

Abstract

Am J Surg

J Vascular Surg

J Diabet Complications

An epidemiological survey of diabetic foot problems in the Stockholm County 1982

Acta Med Scand Suppl

The influence of sepsis and ischemia on the natural history of the diabetic foot

Am Surg

Lower-extremity amputation in people with diabetes. Epidemiology and prevention

Diabetes Care

Prognostic value of systolic ankle and toe blood pressure levels in outcome of diabetic foot ulcer

Diabetes Care

Healing of ulcers on the feet correlated with distal blood pressure measurements in occlusive arterial disease

Acta Orthop Scand

Toe blood pressure a valuable adjunct to ankle pressure measurement for assessing peripheral arterial disease

J Cardiovasc Surg

The relationship of distal systolic pressures to healing of skin lesions in limbs with arterial occlusive disease with special reference to diabetes mellitus

Scand J Clin Lab Invest Suppl

Toe blood pressure by photoplethysmography: An index of healing in forefoot amputation

Surgery

Wound classification is more important that site of ulceration in the outcome of diabetic foot ulcers

Diabetic Med

The importance of peripheral pulses, peripheral oedema and local pain for the outcome of diabetic foot ulcers

Diabetic Med

The dysyascular foot: A system for diagnosis and treatment

Foot Ankle

Original article
Medical risk factors in diabetic patients with foot ulcers and severe peripheral vascular disease and their influence on outcome