Lower extremity chronic diabetic ulcer Skin and Connective Tissue Diseases Ulcer
Conditions
Interventions
Treatment with autologous platelet concentrate versus standard therapy
Sponsors
Harvest Technologies Corp. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Patient and/or his/her legal representative has read and signed the IRB approved Informed Consent Form before treatment 3. Patient or caregiver are willing and able to participate in the clinical trial for the duration of the study and are able to visit the clinic weekly 4. Patient is willing to have blood drawn weekly 5. Patient is compliant with standard wound care regimen assessed over 3 initial observational visits each 7 days apart 6. Patient is diabetic (on insulin or oral hypoglycemic agent) HbAlC 0.7 b. Previously revascularized at least 4 weeks prior to enrolment by bypass or endovascular therapy c. Compromised circulation with ABI 0.4-0.7 in patient not deemed to be a candidate for revascularization because of prohibitive anatomic or physiologic consideration 9. Hematological: a. Hct =30% b. Platelet count =100,000 10. Adequate venous access for phlebotomy 11. Reliable access to outpatient dressing care i.e. home nursing service, family member, patient 12. Serum Albumin >2.5 mg/dl (Stratification: Wagner classification stage I or II OR stage III, creatinine clearance 0.7)
Exclusion criteria
Exclusion criteria: 1. Ulcer is located in area of radiation treatment 2. Active malignancy 3. Being treated with immunosuppressant drugs 4. Patient received biological treatment(s) within 30 days 5. Active infection - if osteomyelitis has been diagnosed, patient may be enrolled only after infection has been controlled 6. Patient has a known alcohol or drug abuse 7. Patient has a non-study ulcer on the study lower extremity that is located within 2.0 cm from the study ulcer at Day 0 8. Patient has been previously diagnosed with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) or hepatitis 9. Patient is undergoing dialysis 10. Ankle Brachial Index <0.4 11. Ankle Brachial Index 0.4-0.7 in patient appropiate for revascularization 12. Venous stasis ulcers. Low leg ulcers in the presence of any of the following are to be excluded: a. Presence of lipodermatosclerosis in the gaitor area of the calf b. Presence of varicose veins c. History of deep venous thrombosis in the index limb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of cases completely healed by 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Germany
Outcome results
None listed