Initial percent change in wound size can predict outcome

NewsBot · Jun 27, 2006

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Percent Change in Wound Area of Diabetic Foot Ulcers over a 4-Week Period Is a Robust Predictor of Complete Healing in a 12-Week Prospective Trial.
Plast Reconstr Surg. 2006 Jun;117(7S SUPPLEMENT):239S-244S

OBJECTIVE:: To assess the ability of the 4-week healing rate to predict complete healing over a 12-week period in a large prospective multicenter trial of diabetic patients with foot ulceration.

RESEARCH DESIGN AND METHODS:: We examined the change in ulcer area over a 4-week period as a predictor of wound healing within 12 weeks in patients who were seen weekly in a prospective, randomized controlled trial.

RESULTS:: Wound area measurements at baseline and after 4 weeks were performed in 203 patients. The midpoint between the percentage area reduction from baseline at 4 weeks in patients healed versus those not healed at 12 weeks was found to be 53%. Subjects with a reduction in ulcer area greater than the 4-week median had a 12-week healing rate of 58%, whereas those with reduction in ulcer area less than the 4-week median had a healing rate of only 9% (P < 0.01). The absolute change in ulcer area at 4 weeks was significantly greater in healers versus nonhealers (1.5 versus 0.8 cm, P < 0.02). The percent change in wound area at 4 weeks in those who healed was 82% (95% CI 70-94), whereas in those who failed to heal, the percent change in wound area was 25% (15-35; P < 0.001).

CONCLUSIONS:: The percent change in foot ulcer area after 4 weeks of observation is a robust predictor of healing at 12 weeks. This simple tool may serve as a pivotal clinical decision point in the care of diabetic foot ulcers for early identification of patients who may not respond to standard care and may need additional treatment.
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NewsBot · Feb 27, 2007

Rate of Healing of Neuropathic Ulcers of the Foot in Diabetes and Its Relationship to Ulcer Duration and Ulcer Area
Paul Ince, Fran L. Game, and William J. Jeffcoate,
Diabetes Care 30:660-663, 2007

OBJECTIVE—To examine the outcome of neuropathic foot ulcers and to seek associations between healing and features of the ulcers at baseline.

RESEARCH DESIGN AND METHODS—Data were collected prospectively during the course of routine management. All patients were selected who presented to a single unit between 1 January 2000 and 31 December 2004 with neuropathic foot ulcers and without evidence of either peripheral arterial disease or infection. Associations were sought between ulcer characteristics at baseline and clinical outcome.

RESULTS—A total of 154 patients (66.9% male) presented with 410 ulcers. Age was 57.4 ± 12.0 years (means ± SD). A total of 178 (43.4%) ulcers were on the plantar aspect of the foot; 73.7% of ulcers had a cross-sectional area of <1 cm2. Median ulcer duration at referral was 15 days (range 1–1,046). Healing without amputation was observed in 91.7%. The percentage of ulcers healed at 12, 20, and 52 weeks were 59.3, 70.5, and 86.6%, respectively. Significant associations were observed between area at referral and outcome type (2 P < 0.0001), prior ulcer duration (Kruskal-Wallis P = 0.006), and time to healing (Kruskal-Wallis P = 0.014), as well as between ulcer duration and time to healing (Spearman , r = 0.104, P = 0.047). There was no difference between plantar and nonplantar ulcers.

CONCLUSIONS—The rate of healing in this cohort provides a benchmark for comparison with other centers. While further work is needed to determine how outcomes can be improved in unselected series such as these, the confirmation of close relationships between ulcer duration at referral, ulcer area, and outcome emphasizes the importance of early expert assessment of newly occurring neuropathic ulcers.
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NewsBot · Aug 22, 2007

The association between baseline characteristics and the outcome of foot lesions in a UK population with diabetes
Diabetic Medicine 24 (9), 977–981.

Aims To explore the relationships between time to healing of diabetic foot ulcers and baseline characteristics of both patients and their ulcers.

Methods All patients were included who were referred to a specialist clinic over a 4-year period. Age, gender, type and duration of diabetes, ulcer site, ulcer duration and baseline characteristics were recorded. Postcode was used to derive an index of social deprivation. Patients were followed up to 1 year. The primary outcome measure was time to healing. Those who died or had an ulcer-related amputation were censored at the time of death or amputation and classified as unhealed.

Results Mean age of 449 participants (63.7% male) was 66.7 years; 42.7% had evidence of peripheral arterial disease, and 80% had peripheral neuropathy. Median ulcer duration at presentation was 29 days; 60.5% ulcers had an area of < 1 cm2 and 68.3% of all ulcers healed without amputation during the follow-up period. Univariate analysis revealed dose–response relationships between time to healing and increasing duration of diabetes, increasing ulcer area, ulcer site and peripheral arterial disease. No associations were found with age, gender, diabetes type, deprivation index, peripheral neuropathy or infection. The relationship between healing time and ulcer area, peripheral arterial disease and diabetes duration remained significant on multivariate analysis.

Conclusions The dominant factors influencing healing are cross-sectional area at presentation and the degree of peripheral arterial disease. Further work is needed to define how those at greatest risk may be identified and best managed.
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NewsBot · Oct 16, 2007

Prediction of healing for post-operative diabetic foot wounds based on early wound area progression.
Lavery LA, Barnes SA, Keith MS, Seaman JW Jr, Armstrong DG.
Diabetes Care. 2007 Oct 12; [Epub ahead of print]

Objective: To evaluate the probability of wound healing based on percent wound area reduction (PWAR) at one week and 4 weeks in persons with large, chronic, non-ischemic diabetic foot wounds following partial foot amputation.

Methods: Data from a 16-week randomized clinical trial (RCT) of 162 patients were analyzed to compare outcomes associated with Negative Pressure Wound Therapy delivered through the VAC Therapy System (KCI USA San Antonio, TX) (NPWT) (n=77) versus standard moist wound therapy (MWT) (n=85). One and 4-week regression models included 153 and 129 of the RCT patients, respectively.

Results: Early changes in PWAR were predictive of final healing at 16 weeks. Specifically, wounds that reached >/=15% PWAR at one week or >/=60% PWAR at four weeks had a 68% and 77% (respectively) probability of healing versus 31% and 30% (respectively) if these wound area reductions were not achieved. Patients receiving NPWT were 2.5 times more likely to achieve both a 15% PWAR at one week and 60% area reduction at one month (odds ratio = 2.51 and 2.49, respectively) compared to MWT.

Conclusion: Results of this study suggest that clinicians can calculate the PWAR of a wound as early as week one of treatment to predict the likelihood of healing at 16 weeks. This might also assist in identifying a rationale to re-evaluate the wound and change wound therapies.
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NewsBot · Jan 25, 2008

Early healing rates and wound area measurements are reliable predictors of later complete wound closure.
Cardinal M, Eisenbud DE, Phillips T, Harding K.
Wound Repair Regen. 2008 Jan-Feb;16(1):19-22.

This study was undertaken to determine if healing rates are reliable early predictors of ultimate complete wound closure in venous leg ulcers and diabetic foot wounds. We conducted a retrospective analysis of 306 venous leg ulcers and 241 diabetic foot ulcers enrolled in two large controlled, prospective, randomized pivotal trials to compare topical wound treatments, to determine whether certain early markers of healing could be correlated with later total wound closure. Two-sided tests at 95% confidence demonstrated that wound margin advance, initial healing rate, percent wound surface area reduction, and wound healing trajectories (all p<0.001) were powerful predictors of complete wound healing at 12 weeks. Wounds with poor healing progress by these criteria at 4 weeks were highly likely to remain unhealed after 8 additional weeks of treatment. Analysis of the diabetic foot ulcers and venous leg ulcers subgroups separately demonstrated consistent statistical test results with high significance; similarly, the results remained valid independent of the topical treatment used. The early prediction of eventual wound healing or nonhealing using early healing rates may enable more efficient triage of patients to advanced healing technologies. We believe that these surrogate markers are robust predictors of healing regardless of wound etiology and that they merit wider use in clinical trials and routine patient care.
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NewsBot · Apr 9, 2008

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.
J Diabetes Complications. 2008 Apr 2;
Coerper S, Beckert S, Küper M, Jekov M, Königsrainer A

INTRODUCTION: 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.

PATIENTS AND METHODS: 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))x100)/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%.

RESULTS: 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) cm(2). 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).

CONCLUSIONS: 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.
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NewsBot · Apr 7, 2010

A Post-hoc Analysis of Reduction in Diabetic Foot Ulcer Size at 4 Weeks as a Predictor of Healing by 12 Weeks.
Ostomy Wound Manage. 2010 Mar;56(3):44-50.Snyder RJ, Cardinal M, Dauphinee DM, Stavosky J.

Percent area reduction (PAR) after 4 weeks of diabetic foot ulcer (DFU) treatment has been suggested as a clinical monitoring parameter to distinguish DFUs that will heal within 12 weeks from those that will not despite standard wound care. The purpose of this post-hoc analysis of control DFU treatment outcomes from two published, randomized, controlled studies was to assess the relationship between PAR during early standard wound care and ulcer closure by week 12. The proportion of DFUs healed after 12 weeks was 57% (39 out of 69; 95% confidence interval [CI], 44% to 68%) in study A and 52% (38 out of 73; 95% CI, 40% to 64%) in study B for wounds with >/=50% PAR by week 4 and 5% (three out of 64; 95% CI, 1% to 13%) and 2% (one out of 44; 95% CI, 0.1% to 12%), respectively, for DFUs with <50% PAR at week 4. Regardless of baseline size category, DFUs with <50% PAR at 4 weeks were less likely to heal by 12 weeks than DFUs with >/=50% PAR (P </= 0.001). Using pooled data, PAR at weeks 1 to 3 also varied between ulcers that did and did not heal after 12 weeks but sensitivity and specificity was highest on week 4. These findings confirm that percent reduction in wound size is an early predictor of treatment outcome and that protocols of care should be re-evaluated if >/=50% PAR is not achieved. Studies to assess DFU healing before and after 4 weeks of standard wound care are needed to further refine these guidelines of care.
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NewsBot · May 21, 2010

A checklist system to score healing progress of diabetic foot ulcers.
Martínez-De Jesús FR.
Int J Low Extrem Wounds. 2010 Jun;9(2):74-83.

The aim of this article was to validate the checklist contribution of 10 factors relevant to healing in order to score the severity of diabetic foot ulcers. A total of 235 patients from January 2007 to January 2009 were scored according to the Saint Elian Wound Score System from mild to severe (1 to 3) in the following categories: location, topographic aspects, and number of affected zones, ischemia, infection, edema, neuropathy, depth, area, and wound healing phase. The score sum was graded as I (score </=10, good prognosis for wound healing), II (11-20, partially foot-threatening), and III (21-30, limb- and life-threatening). The 10 categories showed an increasing trend for score severity. Grade I ulcers were associated with an excellent healing rate of 96% (P < .001) and minor amputations prevailed at grade II (11.2%; odds ratio [OR] = 3, 95% confidence interval [CI] = 0.3-23.6). The chances for major amputation (40.6%; OR = 6.1, 95% CI = 2.7-13.4) and mortality (15.6%; OR = 32.7, 95% CI = 3.7-287) were significantly higher for grade III patients (P < .001). The mean time of healing for grades I, II, and III was 5.8 +/- 5.8, 9.4 +/- 10.5, and 14.4 +/- 12.1 weeks, respectively. In all, 80% of patients achieved total wound healing at 8, 20, and 37 weeks for grades I, II, and III, respectively (P < .001; Kaplan-Meier). The results validated the checklist contribution of 10 wound factors to scoring the severity and healing progress of diabetic foot ulcers.
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NewsBot · Jan 25, 2013

Granulation Response and Partial Wound Closure Predict Healing in Clinical Trials on Advanced Diabetes Foot Ulcers Treated With Recombinant Human Epidermal Growth Factor
Carmen M. Valenzuela-Silva, et al
Diabetes Care February 2013 vol. 36 no. 2 210-215

OBJECTIVE To determine if partial wound closure surrogate markers proposed for neuropathic, small diabetic foot ulcers (DFUs) can be extended to advanced lesions and if the development of granulation tissue can be used to predict complete healing.

RESEARCH DESIGN AND METHODS Data from two multicenter, double-blind, randomized clinical trials (one of them placebo controlled) that used intralesional recombinant human epidermal growth factor (rhEGF) to promote granulation and healing were used. For confirmation in a larger sample from common clinical practice, the results of an active postmarketing surveillance of rhEGF treatment of DFUs in 60 healthcare units was included. The surrogates evaluated were percent area change, log healing rate, ratio of log areas, and percent of granulation tissue covering the wound area. The tests used were surrogate final end point correlation, receiver operating characteristic curves to discriminate healers from nonhealers, validation tests using logistic regression models, and the proportion-mediated estimation.

RESULTS Two weeks >50% granulation, end of treatment >75% granulation, and 16.1% area change showed significant predictive value (>70% correct classification) for final wound closure. The granulation-based variables fulfilled the criterion that the effect of rhEGF treatment on wound closure was mediated by the surrogate.

CONCLUSIONS This work provides the first evidence for the use of granulation tissue development as a predictor of wound healing in advanced DFUs. These results can be useful for clinical trial design, particularly during the exploratory phase of new products.
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NewsBot · Mar 29, 2022

Initial reduction in ulcer size as a prognostic indicator for complete wound healing: a systematic review of diabetic foot and venous leg ulcers
Brenig Llwyd Gwilym et al
Adv Wound Care (New Rochelle). 2022 Mar 27

Significance Percent area reduction (PAR) is commonly reported in trials including diabetic foot ulcers (DFU) and venous leg ulcers (VLU). It's unclear how well PAR performs as a surrogate marker for complete wound closure. This review aimed to summarise all available evidence evaluating PAR as a predictor of complete DFU and VLU healing. Recent Advances A review searching the CENTRAL, MEDLINE, EMBASE, and EMCARE databases was conducted in accordance with PRISMA. Randomised controlled trials and observational studies reporting PAR and any measure of its predictive ability were included. Outcomes included performance measures of PAR, timing of PAR and outcome measurement, and specific PAR cut-offs. Critical Issues Meta-analysis was not possible due to high variability in wound duration at study start (2-48 weeks), PAR timing (2-8 weeks), PAR cut-off (-3 to 90%; determined post-hoc in most studies), and outcome assessment (10-24 weeks). Six studies (21,430 DFU patients) report PAR as having acceptable to outstanding discriminatory ability (C-statistic 0.720-0.910). Five studies (29,775 VLU patients) report PAR as having poor to excellent discriminatory ability (C-statistic 0.680-0.830). One study (241 DFU and VLU patients) reports PAR sensitivity and specificity of 58.5% and 90.5% respectively. All studies were determined to have high risk of bias. Future Directions Despite promising discriminatory ability, most studies report post-hoc analysis of patients in randomised trials, are highly heterogenous in study design, and have high risk of bias. There is scant evidence to support PAR in isolation as a surrogate for complete DFU or VLU healing in routine clinical practice.
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NewsBot · Apr 27, 2022

Further evidence that wound size and duration are strong prognostic markers of diabetic foot ulcer healing
David J Margolis et al
Wound Repair Regen. 2022 Apr 26

Diabetic foot ulcers (DFU) are a critical problem for those with diabetes mellitus. Predicting the healing likelihood of a DFU is important to implementing appropriate care, allocating resources, having access to advanced therapies, having successful clinical trials, calibrating clinical trial results, and providing information to administrative entities on patient and provider outcomes. Prognostic modeling can also be important when attempting to compare results across trials or care centers. In a prospective cohort study, we demonstrate and replicate that simple wound characteristics like wound area and wound duration can be used to predict wound healing by the 16th week of care. The models were based on previous literature and replicated using a machine learning algorithm. The use of wound duration and wound area in a prognostic model continues to be important when comparing study results, center-based outcomes, as well as designing clinical trials.
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