Clinical Efficacy of Acellular Dermal Matrix Paste in Treating Diabetic Foot Ulcers

Myungchul Lee, MD, PhD; Dongkeun Jun, MD; Hyungon Choi, MD, PhD; Jeenam Kim, MD, PhD; Donghyeok Shin, MD, PhD

Wounds. 2020;32(2):50-56.

Conclusions

The results of this study demonstrate the healing effects of ADM paste in Wagner grade 2 or 3 DFUs. As a mixture of micronized ADM and gelatin, this paste readily conforms to geometric and tunneling ulcers, and the initial acceleration of healing documented within 30 days may be particularly advantageous in poorly vascularized diabetic ulcers. Further clinical testing and follow-up monitoring are required to confirm its promise in managing hard-to-heal DFUs

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Table 1. Inclusion and exclusion criteria
Inclusion Criteria	Exclusion Criteria
Aged ≥20 years	Wagner grade 4 (partial foot gangrene) or grade 5 (whole foot gangrene)
Type 1 or type 2 DM^a	Uncontrolled infection at index ulcer
Ulcers with diabetic origin, >1cm², located on the foot below malleoli	Ischemic DFUs (prominent arterial occlusion requiring intervention on CT angiography)
Ulcer present for at least 4 weeks	Previous ulcer treatment using a biochemical or topical growth factor within 30 days
Wagner grade 2 (probing to tendon or capsule) or grade 3 (deep with osteitis)	Compromised renal function (serum creatinine ≥3.0mg/dL)
Patent arteries on CT angiography	HbA_1c >12% within 60 days
Triphasic or biphasic Doppler arterial waveforms at the ankle level	Patients with known skin malignancy on the index ulcer
No definite bacterial growth or controlled flora (few colony-forming units) on serial wound cultures	Patients with uncontrolled autoimmune disease
Adequate renal function (serum creatinine <3.0mg/dL)	Patients with ongoing chemotherapy or radiation therapy
HbA_1c levels <9%

DM: diabetes mellitus; CT: computed tomography; HbA_1c: hemoglobin A_1c
^aAmerican Diabetes Association diagnostic criteria was used.

Table 2. Patient demographics summarized by group
	Treatment Group (n=23)	Control Group (n=26)
Age (y)	60.26±13.84	62.12±14.96
Gender
Male	13 (56.5%)	16 (61.5%)
Female	10 (43.5%)	10 (38.5%)
BMI (kg/m²)	28.79±4.64	28.5±4.4
Hb (g/dL)	12.82±2.86	13.2±1.6
HbA _1c(%)	8.21±1.39	7.82±1.2
Albumin (g/dL)	3.32±0.38	3.2±0.41
Ulcer location
Toe	10 (43.5%)	11 (42.3%)
Forefoot	3 (13.0%)	5 (19.2%)
Midfoot	8 (34.8%)	8 (30.8%)
Hindfoot	2 (8.7%)	2 (7.7%)

Continuous variables are presented as mean±standard deviation (SD) and categorical variables as number (n) and percentage (%).
y: year; BMI: body mass index; Hb: hemoglobin

Table 3. Clinical characteristics and outcomes of treated foot ulcers
		Treatment Group (n=23)	Control Group (n=26)
Wagner classification (grade 2/3; n)		20/3	25/1
Ulcer area (cm²)
Initial	Mean±SD	13.81±19.30	7.97±10.00
Initial	Range (min–max)	0.78–62.64	0.24–34.44
Final	Mean±SD	6.87±10.52	5.90±8.31
Final	Range (min–max)	0–30.6	0–29.64
Ulcer depth (cm)
Initial	Mean±SD	1.03±1.23	0.93±0.63
Initial	Range (min–max)	0.2–5.7	0.2–3.2
Final	Mean±SD	0.07±0.13	0.57±0.67
Final	Range (min–max)	0–0.6	0–3
Follow-up period (d)^a	Mean±SD	33.74±24.51	51.12±17.39
Follow-up period (d)^a	Range (min–max)	6–60	9–60
Time to complete healing (d)^a	Mean±SD	13.54±9.18	21.5±11.98
Time to complete healing (d)^a	Range (min–max)	6–35	9–42

SD: standard deviation; min: minimum; max: maximum; d: day
^aDays within research period (ie, 60 days).

Table 4. Ulcer resolution rates compared by group
		Treatment Group (n=23)	Control Group (n=26)	P Value
Decrease rate (%)	Area (95% CI)	74.17±30.84 (60.78–87.45)	51.87±32.81 (38.62–65.12)	.0187
Decrease rate (%)	Depth (95% CI)	87.18±18.96 (78.98–98.39)	45.98±32.89 (32.70–59.27)	<.001

SD: standard deviation; CI: confidence interval

Table 5. Complete healing rates compared by group
		Treatment Group (n=23)	Control Group (n=26)	P Value
Complete healing	Patients (n)	13	6	.016
Complete healing	Rate (%)	56.52	23.08	.016

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