Chronic limb threatening ischemia and ischemic wound Negative pressure wound therapy Topical oxygen therapy Ischemic foot ulcer Chronic limb threatening ischemia Revascularization Granulation tissue
Conditions
Interventions
1 Adequate pain control and wound debridement.
2 Standard negative pressure wound therapy at pressure -75 mmHg with a-sterile tube connected to O2 supplier with O2 flow 3 L per min for daily 90 min pe
Experimental Device,Placebo Comparator Device
Topical oxygen therapy,Standard negative pressure wound therapy
Sponsors
Rajavithi Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients were diagnosed Chronic limb threatening ischemia with ischemic foot ulcer 2.Successful below knee revascularization at least 2 of 3 vessels such as anterior tibial artery , posterior tibial artery, pernoneal artery. 3. Age more than 18 years old 4. Pre-treatment serum albumin more than 3 gram/dL
Exclusion criteria
Exclusion criteria: 1. Patients do not have contraindication for endovascular revascularization 2. Unsuccessful revascularized patients or successful revascularization only 1 of 3 vessels. 3. Patients who was performed a major amputation (ex. below knee amputation or above knee amputation) of index limb. 4. Patients with combined chronic arterial and venous insufficiency. 5. Patients who is taking the steriod drugs, immunosuppressive drugs or antineoplastic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete wound granulation tissue at the time wound bed is filled with granulation tissue full wound bed granulation tissue | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound size reduction from start treatment to the complete research study. (at least 12 weeks of follow up.) Wound area is equal to longest width x length,Complete wound healing time from start treatment to the complete research study (at least 12 weeks of follow up.) Time from start treatment to complete wound epithelialization,Hospitalization time from start treatment to the complete research study (at least 12 weeks of follow up). total days of hospitalization which associated with wound care.,Limb salvage from start treatment to complete research study (at least 12 weeks of follow up) Number of limb salvage during reseach,Wound recurrence after discharge from hospital to the complete reseach study. (at least 12 weeks follow up) Wound recurrence at the same area of healed or complete granulation wound in the index limb,Wound complication from start treatment to complete research study (at least 12 weeks) the complications related to the index wound such as wound infection (confirmed by culture), wound edge marceration, wound necrosis confirmed by expert clinician. | — |
Countries
Thailand
Contacts
Public ContactNAPAT SARAYUTPITAK
Rajavithi hospital
Outcome results
None listed