Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
KCI USA, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Presence of a calcaneal, dorsal or plantar diabetic foot ulcer ≥ 2 cm2 in area after debridement. (If more than one ulcer is present, all wounds will be treated using the same method, but only one ulcer will be studied.)
DFU equivalent to Stage 2 or greater, as defined by Wagner's Scale system (See Appendix E)
Evidence of adequate perfusion by one of the following on the affected extremity,(within the past 60 days):Dorsum transcutaneous oxygen test (TcPO2) with results of ≥30 mmHg, or ABIs with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmHg, or Doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg.
Age ≥ 18 years of age
HbA1c ≤ 12% (collected within the last 90 days.)
Evidence of adequate nutrition by one of the following:
Lab results reflecting Pre-Albumin \>16 mg/dl and Albumin level is \>3 g/dl (during the seven days prior to the study period), or a nutritional consult will be done and with appropriate supplementation started. Proper documentation on CRFs is needed.
You may not be if
Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group
Ulcers resulting from electrical, chemical, or radiation burns, or venous insufficiency
Untreated infection or cellulites at site of target ulcer
Presence of untreated osteomyelitis
Collagen vascular disease
Malignancy in the ulcer
Presence of necrotic tissue
Uncontrolled hyperglycemia
Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
Open amputations
Prior V.A.C. therapy within 30 days.
Current or prior normothermic (Warm-UP®) or HBO therapy within 30 days.
Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren)
Current or prior treatment with skin or dermal substitutes and dressings (Examples: Apligraft, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.
Current use of any enzymatic debridment agent (Example: Acuzyme /Panafil) during the active treatment phase of the study
Pregnant or nursing mothers.
Clareo Health | Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers
