1. MIXED CHRONIC LEG ULCER Palliative treatment results on 132 patients Enrique G. Bertranou Enrique G. Bertranou José Antonio Olivencia José Antonio Olivencia Sergio E. Gonorazky Hospital Privado de Comunidad. Mar del Plata, Argentina Iowa Vein Center. Des Moines, Iowa

2. The similar clinical features of a group of chronic leg ulcer, permit its inclusion under a distinct group called: “mixed chronic leg ulcer” (MCLU) for its better management. INTRODUCTION

3. BRIEF DEFINITION OF THE NEW CLINICAL ENTITY Leg ulcer resulting of chronic, progressive and irreversible impairment of the venous, arteriolar and lymphatic circulation, in aged patients with unbearable pain and remote possibilities of cure.

4. OBJECTIVES Description of mixed chronic leg ulcer Description of mixed chronic leg ulcer(MCLU). Description of the leg ulcer palliative Description of the leg ulcer palliative care program (LUPC). Evaluation of 12 year – leg ulcer palliative Evaluation of 12 year – leg ulcer palliative care program (LUPC). Determination of mixed chronic leg ulcer Determination of mixed chronic leg ulcer survival rate. Survival rate comparison between MCLU Survival rate comparison between MCLU and matched control group.

5. CLINICAL FEATURES Elderly patients. Frequently women. Background of venous and/or arteriolar ulcer. Extensive, profound, necrotic, transudating ulcer. Unbearable pain (mostly by night). Torpid evolution. No peripheral pulses. No foot gangrene. Arterial hypertension. No cognitive deterioration. Remote possibilities of cure.

6. Mixed chronic leg ulcer Venous ulcer in origin

7. Mixed chronic leg ulcer Martorell’s arteriolar hypertensive ulcer in origin

8. PATHOGENESIS A ) SVI and/or DVI chronic venous ulcer physiologic senescence arteriosclerosis arterial hypertension arteriolosclerosis diabetes (?) extreme impairment of macro and micro circulation skin hypoxia of foot and leg mixed chronic leg ulcer. B) Chronic Martorell’s arteriolar hypertensive ulcer without venous pathology physiologic senescence venous pathology physiologic senescence arteriosclerosis arterial hypertension arteriolosclerosis diabetes ( ?) extreme impairment of macro and micro diabetes ( ?) extreme impairment of macro and micro circulation skin hypoxia of foot and leg circulation skin hypoxia of foot and leg mixed chronic leg ulcer. mixed chronic leg ulcer.

9. Increased leukocyte activation Increased leukocyte activation Metalloproteinase inhibitors Metalloproteinase inhibitors Fibroblasts senescence Fibroblasts senescence Degradation of angiogenic mediators Degradation of angiogenic mediators (growth factor ß1) Antiendothelian cell antibodies Antiendothelian cell antibodies Plasminogen activation with proteolitic activity Plasminogen activation with proteolitic activity High rate of antithrombin deficiency. High rate of antithrombin deficiency. RECENT WORK CONCERNING ULCER HEALING

10. LEG ULCER PALLIATIVE CARE (LUPC) PROGRAM Oral and written information to patient and family about Oral and written information to patient and family about the disease and its remote possibility of cure. the disease and its remote possibility of cure. Self ulcer dressing at home: silver sulfadiazine or chloranfenicol Self ulcer dressing at home: silver sulfadiazine or chloranfenicol ointments alternatively twice a day, 30 mmHg elastic bandage. ointments alternatively twice a day, 30 mmHg elastic bandage. Weekly visit to the Ulcer Clinic: necrotic tissue debridement, Weekly visit to the Ulcer Clinic: necrotic tissue debridement, denudated tendon resection (if any), medical treatment control. denudated tendon resection (if any), medical treatment control. Treatment of pain (progressive steps following pain intensity). Treatment of pain (progressive steps following pain intensity). Avoid complex and vain diagnostic and therapeutic methods. Avoid complex and vain diagnostic and therapeutic methods. Eliminate unrealistic expectation of healing. Eliminate unrealistic expectation of healing.

11. PATIENTS PATIENTS Study period: April 1990 – October 2002 Patients Number Age on entering Standard Error the program the program Total 132 Women 93 74,5 years 1,4 years p = NS p = NS Men 37 71,7 years 1,4 years

12. SURVIVAL RATE SURVIVAL RATE Actuarial analysis (Kaplan-Meier) Actuarial analysis (Kaplan-Meier) Patients: 132 Deceased: 58 Censored: 74 amputees: 5 lost in the follow-up: 46 end of study: 23 end of study: 23 PATIENTS

14. CASE-CONTROL STUDY CASE-CONTROL STUDY FROM RANDOMIZED CAPTIVE POPULATION Actuarial analysis (Kaplan-Meier, Wilcoxon) Study group : 78 patients. Control group : 78 individuals matched by gender and age on entering the palliative program. PATIENTS

15. p = NS

16. Satisfactory patient/family treatment compliance. Adequate pain management. Adequate pain management. Cellulitis with hospitalization: 11 patients (8,3%). Cellulitis with hospitalization: 11 patients (8,3%). Desertion from program with ulterior reentry: Desertion from program with ulterior reentry: 11 patients (8,3%). Actuarial survival: 1st year: 93%, 6th year: 53%, Actuarial survival: 1st year: 93%, 6th year: 53%, 12th year 0%. Median survival: 7,2 years. Median survival: 7,2 years. Treatment cost: $152 patient/month. Treatment cost: $152 patient/month. No survival difference between patients with No survival difference between patients with mixed leg ulcer and general population. RESULTS

17. 1)Patient/family compliance of leg ulcer palliative care program resulted in adequate ulcer maintenance and satisfactory pain control. 2) The patient survival rate was high despite the presence of MCLU. 3) No survival rate difference between patients and controls. 4) Leg ulcer palliative care program offer quality of life on these incurable patients. on these incurable patients. 5) MCLU management with complex diagnostic and therapeutic methods is futile. CONCLUSIONS