Effect of micronized acellular dermal matrix on wound healing and granulation tissue formation in delayed wounds of diabetic foot ulcer patients.

Not Applicable

Completed

Conditions: Diseases of the skin and subcutaneous tissue

Registration Number: KCT0004373

Lead Sponsor: Ajou University Hospital

Brief Summary: Acellular dermal matrix has been successfully used to heal diabetic foot ulcers. While conventional sheet-type dermal matrix promises wound healing, we report on our study to examine the clinical outcomes of a ready-to-use micronized dermal matrix for diabetic foot ulcers, comparing that with conventional negative pressure wound therapy. This was a prospective, randomized, pilot study of comparing micronized human acellular dermal matrix as an adjunctive treatment for diabetic foot ulcers that required operative debridement with conventional negative pressure wound therapy only. We randomly allocated 30 diabetic foot wounds of Wagner grade 2 or higher in 30 adult patients into 1 of 2 groups. The control group (n=15) was treated with conventional negative pressure wound therapy, and the experimental group (n=15) was treated with micronized dermal matrix and negative pressure wound dressing. We evaluated outcomes included granulation tissue formation, proportion of patients with closed or covered wound at 42 days and at 120 days, achieving complete wound healing during six months of follow-up, and intervals from enrollment to final surgical procedures. One patient in the conventional therapy group withdrew two days after enrollment due to major amputation. All 15 wounds treated with micronized matrix showed healthy granulation tissue without noticeable complications during follow-up. At 42 days, 46.7% of the experimental group had closed compared with 28.6% in the conventional therapy group (p = 0.007). At 120 days, 86.7% of the experimental group had closed completely compared with 57.1% in the conventional therapy group (p = 0.040). During the six-month follow-up period, 93.3% of the experimental group achieved complete wound healing compared with 85.7% of the conventional therapy group (p = 0.468). The healing outcomes in the experimental group were accelerated when combined with the use of negative pressure therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 29

Inclusion Criteria

1. Patients who are 18 years of age or older
2. Patients who had diagnosis of type 1 or type 2 diabetes with at least one nonhealing neuropathic or vasculopathic foot ulcer that failed following a minimum of four weeks of conservative care prior to study enrollment.
3. Patients who have foot ulcers of stage 2 or higher on Wagner’s scale and require operative intervention.
* If a single patient had multiple wounds, we selected the deepest wound.
4. Subjects who have agreed to participate in this clinical trial

Exclusion Criteria

1. inadequate nutrition as assessed by a blood sample of serum albumin with a value less than 2.0 g/dL
2. malignancy
3. autoimmune disease
4. using long-term corticosteroids or immunosuppressants
5. uncontrolled hyperglycemia (preoperative HbA1c >15.0%)
* patients who had undergone amputation above the level of the study wound.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
granulation tissue formation (%);complete wound healing rate (%)

Secondary Outcome Measures

Name	Time	Method
proportions of wounds that were surgically closed or covered without complications or that were completely healed;proportions of wounds that were surgically closed or covered without complications or that were completely healed;intervals between study enrollment and surgical coverage;Adverse events included wound infection, surgical complications